International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
NCT ID: NCT01471522
Last Updated: 2023-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
5179 participants
INTERVENTIONAL
2012-07-31
2023-05-30
Brief Summary
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SPECIFIC AIMS
A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure in participants with SIHD and moderate or severe ischemia over an average follow-up of approximately 3.5 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT.
B. Secondary Aims Secondary aims are to determine whether an initial invasive strategy compared to a conservative strategy will improve: 1) the composite of CV death or MI; 2) angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire; 3) all-cause mortality; 4) net clinical benefit assessed by including stroke in the primary and secondary composite endpoints; and 5) individual components of the composite endpoints.
Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III per NIH
Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III per NIH
Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III per NIH
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Detailed Description
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Evidence supporting a routine invasive practice paradigm for patients with SIHD is outdated. In strategy trials conducted in the 1970s, coronary artery bypass grafting (CABG) improved survival as compared with no CABG in SIHD patients with high-risk anatomic features. The relevance of these studies today is speculative because contemporary secondary prevention-aspirin, beta-blockers, statins, ACE inhibitors, and lifestyle interventions-were used minimally if at all. Subsequent trials have compared percutaneous coronary intervention (PCI) with medical therapy, as PCI has replaced CABG as the dominant method of revascularization for SIHD. To date, PCI has not been shown to reduce death or myocardial infarction (MI) compared with medical therapy in SIHD patients.
COURAGE and BARI 2D, the two largest trials comparing coronary revascularization vs. medical therapy in SIHD patients, found that among patients selected on the basis of coronary anatomy after cardiac catheterization, an initial management strategy of coronary revascularization (PCI, PCI or CABG, respectively) did not reduce the primary endpoints of death or MI (COURAGE), or death (BARI 2D) compared with OMT alone. These data suggest, but do not prove, that routine cardiac catheterization--which often leads to ad hoc PCI through the diagnostic-therapeutic cascade--may not be required in SIHD patients. However, most patients enrolled in COURAGE and BARI 2D who had ischemia severity documented at baseline had only mild or moderate ischemia, leaving open the question of the appropriate role of cardiac catheterization and revascularization among higher-risk patients with more severe ischemia. Observational data suggest that revascularization of patients with moderate-to-severe ischemia is associated with a lower mortality than medical therapy alone, but such data cannot establish a cause and effect relationship. In clinical practice only about half such patients are referred for cardiac catheterization, indicating equipoise. Furthermore, analysis of outcomes for 468 COURAGE patients with moderate-to-severe ischemia at baseline did not reveal a benefit from PCI. This issue cannot be resolved using available data because all prior SIHD strategy trials enrolled patients after cardiac catheterization, introducing undefined selection biases (e.g., highest risk patients not enrolled) and making translation of study results problematic for clinicians managing patients who have not yet had cardiac catheterization.
A clinical trial in SIHD patients uniformly at higher risk (which could not have been performed before COURAGE and BARI 2D results were available) is needed to inform optimal management for such patients.
DESIGN NARRATIVE, INCLUDING MODIFICATIONS DURING THE TRIAL
Primary Endpoint
A composite of CV death, MI, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure was proposed as the primary endpoint in the application that was funded by NLHBI, with a secondary endpoint of CV death or MI. Study protocol version 1.0 was finalized on January 18, 2012 after review and approval by the protocol review committee (DSMB) with the primary endpoint specified as the composite of CV death or MI. Regarding the final status of the primary endpoint, the protocol stated:
"To ensure that the primary analysis is well-powered and useful, a prospective plan to allow extending follow-up and/or changing the primary endpoint based on aggregate event rate data will be established prior to the first review of unblinded trial data. At a designated time during the trial, an analysis will be conducted to estimate the overall aggregate primary endpoint event rate and project the final number of observed events. If the estimated unconditional power (i.e. based on aggregate event rate data; not by treatment group) is less than the originally targeted 90%, then one or more of the following options will be considered:
1. Extend follow-up to allow more events to accrue.
2. Change the primary endpoint to one that occurs more frequently. The current primary endpoint would become a secondary endpoint. The proposed new primary endpoint would be the composite of CV death, MI, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure.
3. Follow the recommendation of an independent advisory panel. An independent advisory panel, separate from the DSMB, will be convened for the purpose of reviewing unconditional power estimates and making a recommendation to the NHLBI Director. Members of this panel will not have access to unblinded data by treatment group or other data that may bias their recommendation." All 5 event types were adjudicated throughout the trial. Study protocol v2.0 (January 2014) allowed ischemia eligibility by non-imaging exercise stress test if more stringent (≥70% stenosis) CCTA criteria were met. The 2016 protocol addendum describes the NHLBI-approved reduction in sample size and extension of recruitment and follow-up due to slower than projected recruitment.
The pre-specified first analysis for monitoring and projecting the final aggregate number of primary endpoint events was conducted in 2015. In 2016, the projected need to increase the power by extending follow-up and elevating the 5-component secondary endpoint to become primary was discussed at Steering Committee and Investigator meetings and communicated by email.
An Independent Advisory Panel convened by NHLBI met in May 2017, and in June 2017 NHLBI approved the Independent Advisory Panel's recommendation to elevate the 5-component secondary endpoint to become primary and retain the 2-component composite as a key secondary endpoint. The panel also recommended extension of follow-up. This was communicated to the Steering Committee and Investigators at August and November 2017 meetings and by email. The last visit date was June 30, 2019.
A statistical plan developed for the Independent Advisory Panel process in 2012 specified that a decision about changing the primary endpoint would be targeted to occur before 75% of the final number of primary endpoint events had accrued. Although the final number of primary endpoint events was unknown during the course of the trial, estimates performed at the time of the Advisory Panel meeting suggested that the ratio of accrued endpoint events to final endpoint events was below 50%. See Maron DJ et al. Am Heart J. 2018 201:124-135. PMC6005768 for additional details about modifications to the trial while it was being conducted.
Analysis of Patients' Health Status as a Key Secondary Endpoint
A key secondary objective of the ISCHEMIA trial is to compare the quality of life outcomes-patients' symptoms, functioning and well-being-between those assigned to an invasive strategy as compared with a conservative strategy. In the protocol, angina frequency and disease-specific quality of life measured by the Seattle Angina Questionnaire (SAQ) Angina Frequency and Quality of Life scales, respectively, are described as the tools that will be used to make this comparative assessment. Recent work has indicated that it is possible to combine the information from the individual domain scores in the SAQ into a new Summary Score that captures the information from the SAQ Angina Frequency, Physical Limitation and Quality of Life scales into a single overall score. The advantages of using a summary score as the primary measure of QOL effects of a therapy are a single primary endpoint comparison rather than two or three (eliminating concerns some may have about multiple comparisons) and a more intuitive holistic (patient-centric) interpretation of the effectiveness results. With these advantages in mind, the ISCHEMIA leadership has agreed that the SAQ Summary Score will be designated as the primary way this outcome for this key secondary endpoint of the ISCHEMIA trial will be analyzed and interpreted, with the individual SAQ scores being used in a secondary, explanatory and descriptive role.
PARTICIPATING COUNTRIES:
North America:
Canada; Mexico; USA
South America:
Argentina; Brazil; Peru
Asia:
China; India; Japan; Malaysia; Singapore; Taiwan; Thailand; Russian Federation
Pacifica:
Australia; New Zealand
Europe:
Austria; Belgium; France; Germany; Hungary; Italy; Lithuania; Macedonia; Netherlands; Poland; Portugal; Romania; Serbia; Spain; Sweden; Switzerland; UK
Middle East:
Egypt; Israel; Saudi Arabia
Africa:
South Africa
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Invasive Strategy (INV)
Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy.
cardiac catheterization
Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization.
coronary artery bypass graft surgery
Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, "cabbage"). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart.
percutaneous coronary intervention
Percutaneous coronary intervention may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.
Lifestyle
diet, physical activity, smoking cessation
Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Conservative Strategy
Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms.
Lifestyle
diet, physical activity, smoking cessation
Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Interventions
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cardiac catheterization
Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization.
coronary artery bypass graft surgery
Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, "cabbage"). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart.
percutaneous coronary intervention
Percutaneous coronary intervention may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.
Lifestyle
diet, physical activity, smoking cessation
Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
* Participant is willing to give written informed consent
* Age ≥ 21 years
Exclusion Criteria
* History of unprotected left main stenosis \>50% on prior coronary computed tomography angiography (CCTA) or prior cardiac catheterization (if available)
* Finding of "no obstructive CAD" (\<50% stenosis in all major epicardial vessels) on prior CCTA or prior catheterization, performed within 12 months
* Coronary anatomy unsuitable for either PCI or CABG
* Unacceptable level of angina despite maximal medical therapy
* Very dissatisfied with medical management of angina
* History of noncompliance with medical therapy
* Acute coronary syndrome within the previous 2 months
* PCI within the previous 12 months
* Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
* History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia not due to a transient reversible cause
* NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months
* Non-ischemic dilated or hypertrophic cardiomyopathy
* End stage renal disease on dialysis or estimated glomerular filtration rate (eGFR) \<30mL/min (not an exclusion criterion for CKD ancillary trial, see CKD ancillary trial, Section 18)
* Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
* Allergy to radiographic contrast that cannot be adequately pre-medicated, or any prior anaphylaxis to radiographic contrast
* Planned major surgery necessitating interruption of dual antiplatelet therapy (note that patients may be eligible after planned surgery)
* Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
* Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable)
* Patient who, in the judgment of the patient's physician, is likely to have significant unprotected left main stenosis (Those who are able to undergo CCTA will have visual assessment of the left main coronary artery by the CCTA core lab)
* Enrolled in a competing trial that involves a non-approved cardiac drug or device
* Inability to comply with the protocol
* Exceeds the weight or size limit for CCTA or cardiac catheterization at the site
* Canadian Cardiovascular Society Class III angina of recent onset, OR angina of any class with a rapidly progressive or accelerating pattern
* Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina
* High risk of bleeding which would contraindicate the use of dual antiplatelet therapy
* Cardiac transplant recipient
* Prior CABG, unless CABG was performed more than 12 months ago, and coronary anatomy has been demonstrated to be suitable for PCI or repeat CABG to accomplish complete revascularization of ischemic areas (CCC approval required)
21 Years
ALL
No
Sponsors
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New York University
OTHER
Stanford University
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Albany Stratton VA Medical Center
FED
Cedars-Sinai Medical Center
OTHER
Columbia University
OTHER
Duke University
OTHER
East Carolina University
OTHER
Emory University
OTHER
Harvard University
OTHER
Massachusetts General Hospital
OTHER
Montreal Heart Institute
OTHER
University of British Columbia
OTHER
University of Missouri, Kansas City
OTHER
Vanderbilt University
OTHER
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Judith S Hochman, MD
Role: STUDY_CHAIR
New York University
David J Maron, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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UAB Vascular Biology and Hypertension Program
Birmingham, Alabama, United States
Yuma Regional Medical Center
Yuma, Arizona, United States
Cedars Sinai Medical Center
Beverly Hills, California, United States
UCSF - Fresno Community Regional Medical Center
Fresno, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
University of California Irvine Medical Center
Orange, California, United States
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States
VA Palo Alto HealthCare System
Palo Alto, California, United States
Kaiser Permanente San Jose
San Jose, California, United States
Coastal Heart Medical Group
Santa Ana, California, United States
Stanford University School of Medicine
Stanford, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
South Denver Cardiology Associates, P.C.
Littleton, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
VA Connecticut Healthcare System
West Haven, Connecticut, United States
Daytona Heart Group
Daytona Beach, Florida, United States
Malcom Randall VAMC
Gainesville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Advanced Heart Care Group
Fairview Heights, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana University/Krannert Institute of Cardiology
Indianapolis, Indiana, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Lexington VA Medical Center
Lexington, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Cardiovascular Specialists of Southwest Louisiana
Lake Charles, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Brigham & Women's Hospital, Harvard Medical School
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
VA Boston Healthcare System
West Roxbury, Massachusetts, United States
Saint Vincent Hospital at Worcester Medical Center
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Covenant Medical Center, Inc.
Saginaw, Michigan, United States
Providence - Providence Park Hospital
Southfield, Michigan, United States
Michigan Heart, PC
Ypsilanti, Michigan, United States
Minneapolis VAMC
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
HealthEast Saint Joseph's Hospital
Saint Paul, Minnesota, United States
Saint Luke's Hospital
Kansas City, Missouri, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
Hackensack University Medical Center
Saddle Brook, New Jersey, United States
Albany Medical Center Hospital
Albany, New York, United States
Samuel Stratton VA Medical Center of Albany NY
Albany, New York, United States
Capital Cardiology Associates
Albany, New York, United States
NYU-HHC Kings County Hospital Center
Brooklyn, New York, United States
New York -Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, United States
NYU-HHC Woodhull Hospital
Brooklyn, New York, United States
Coney Island Hospital
Brooklyn, New York, United States
NYP Medical Medical Group Hudson Valley Cardiology
Cortlandt Manor, New York, United States
New York University - Langone Cardiovascular Associates
Flushing, New York, United States
Mid Valley Cardiology
Kingston, New York, United States
Northwell Health - Manhasset
Manhasset, New York, United States
NYU Winthrop
Mineola, New York, United States
VA New York Harbor Health Care System
New York, New York, United States
Beth Israel Medical Center
New York, New York, United States
NYU Langone Medical Center-Bellevue Hospital
New York, New York, United States
NYU New York Medical Associates
New York, New York, United States
Mount Sinai Saint Luke's Hospital
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Cardiology Associates of Schenectady P.C.
Schenectady, New York, United States
NYU-HHC Lincoln Medical and Mental Health Center
The Bronx, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Asheville Cardiology Associates
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Sanford Health
Fargo, North Dakota, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, United States
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, United States
Ohio Health Grant Medical Center
Columbus, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Providence Heart and Vascular Institute
Portland, Oregon, United States
Saint Luke's Hospital and Health Network
Bethlehem, Pennsylvania, United States
Holy Spirit Hospital Cardiovascular Institute
Camp Hill, Pennsylvania, United States
Doylestown Health Cardiology
Doylestown, Pennsylvania, United States
Conemaugh Valley Memorial Hospital
Johnstown, Pennsylvania, United States
Miriam Hospital
Providence, Rhode Island, United States
Kent Hospital
Warwick, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Saint Thomas Hospital
Nashville, Tennessee, United States
V.A. North Texas Health Care System
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
Houston Heart & Vascular Associates
Houston, Texas, United States
Baylor Research Institute at Legacy Heart Center
Plano, Texas, United States
The Heart Hospital Baylor
Plano, Texas, United States
Audie Murphy V.A.
San Antonio, Texas, United States
Medicus Alliance Clinical Research Org., Inc.
Sugar Land, Texas, United States
Wichita Falls Heart Clinic
Wichita Falls, Texas, United States
Salt Lake City VA Medical Center
Salt Lake City, Utah, United States
VAMC-White River Junction
White River Junction, Vermont, United States
Cardiovascular Associates, Ltd.
Chesapeake, Virginia, United States
Stroobants Cardiovascular Center
Lynchburg, Virginia, United States
Winchester Cardiology and Vascular Medicine, PC
Winchester, Virginia, United States
University of Washington Medical Center
Bellevue, Washington, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Hospital Italiano Regional del Sur Bahia Blanca
Bahía Blanca, Buenos Aires, Argentina
Fundacion Favaloro
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto Medico DAMIC
Córdoba, CBA, Argentina
Clinica Del Prado
Córdoba, , Argentina
Clinica Romagosa and Clinica De La Familia
Córdoba, , Argentina
Clínica Privada Vélez Sarsfield
Córdoba, , Argentina
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
LKH Graz West Austria
Graz, Stmk, Austria
Medical University of Vienna, Department of Cardiology
Vienna, Vienna, Austria
Wilhelminen Hospital Vienna
Vienna, Vienna, Austria
University Hospital Leuven
Leuven, Brabant, Belgium
Fundacao Bahiana de Cardilogia
Salvador, Estado de Bahia, Brazil
Hospital Lifecenter
Belo Horizonte, Minas Gerais, Brazil
Hospital Maternidade e Pronto Socorro Santa Lucia
Poços de Caldas, Minas Gerais, Brazil
Quanta Diagnostico & Terapia
Curitiba, Paraná, Brazil
Hospital Cardiologico Costantini
Curitiba, Paraná, Brazil
Hospital Pró-Cardíaco
Botafogo, Rio de Janeiro, Brazil
Hospital Sao Vicente de Paulo
Fundo, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sol
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Cardiologia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Dante Pazzanese de Cardiologia
Ibirapuera, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil
Hospital TotalCor
São Paulo, São Paulo, Brazil
Hospital da Bahia
Salvador, , Brazil
Unifesp - Hospital Sao Paulo
São Paulo, , Brazil
Heart Institute (InCor) University of São Paulo
São Paulo, , Brazil
Hospital Celso Pierro
São Paulo, , Brazil
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
West Lincoln Memorial Hospital
Grimsby, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Dixie Medical Group
Mississauga, Ontario, Canada
Dr. James Cha
Oshawa, Ontario, Canada
Scarborough Cardiology Research
Scarborough Village, Ontario, Canada
Saint Catharines General Hospital
St. Catharines, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Northwest GTA Cardiovascular and Heart Rhythm Program
Vaughan, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux du Montréal
Montreal, Quebec, Canada
CISSSL - Hopital Pierre-Le Gardeur
Terrebonne, Quebec, Canada
Centre Hospitalier de Regional Trois-Rivieres
Trois-Rivières, Quebec, Canada
University of Ottawa Heart Institute
Ottawa, , Canada
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital
Beijing, Chaoyang, China
Liangxiang Hospital, Beijing Fangshan District
Beijing, Fangshan, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Tangshan Gongren Hospital
Tangshan, Hebei, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Medical College
Wuhan, Hubei, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Wuhan Union Hospital, Tongji Medical College, Huazhong Science and Tech University
Wuhan, Hubei, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Qingdao Fuwai Hospital
Qingdao, Shandong, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital
Xian, Shanxi, China
TEDA International Cardiovascular Hospital
Tianjing, Tianjing, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Cairo University
Cairo, , Egypt
C.H. Louis Pasteur
Châtres, Centre-Val de Loire, France
Grenoble University Hospital
Grenoble, Isere, France
Centre Hospitalier Universitaire d'Angers
Angers, Pays de la Loire Region, France
Ambroise Pare Hospital
Boulogne-Billancourt, Île-de-France Region, France
Antoine-Beclere Hospital
Clamart, Île-de-France Region, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, Île-de-France Region, France
Bichat Hospital
Paris, Île-de-France Region, France
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
Universitatsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Praxisklinik Herz Und Gefaesse
Dresden, Saxony, Germany
University Hospital Jena
Jena, Thuringia, Germany
University of Szeged
Szeged, Szeged Megyei Varos, Hungary
Eszszk- Szent Istvan Hospital
Budapest, , Hungary
Military Hospital, Budapest
Budapest, , Hungary
Heart and Vascular Center, Semmelweis University
Budapest, , Hungary
George Gottsegen National Institute of Cardiology
Budapest, , Hungary
Gurunanak CARE Hospital
Hyderabad, Andhra Pradesh, India
CARE Hospital
Hyderabad, Andhra Pradesh, India
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Bangalore, Karnataka, India
Government Medical College
Calicut, Kerala, India
MOSC Medical College Hospital, Kolenchery
Kolenchery, Kerala, India
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Trivandrum, Kerala, India
Ruby Hall Clinic,Grant Medical Foundation
Pune, Maharashtra, India
KEM Hospital Pune
Pune, Maharashtra, India
Dr Ram Manohar Lohia Hospital
New Delhi, National Capital Territory of Delhi, India
Fortis Escort Heart Institute
New Delhi, National Capital Territory of Delhi, India
Batra Hospital and Medical Research Centre (BHMRC)
New Delhi, National Capital Territory of Delhi, India
Fortis Healthcare Fl.t Lt. Rajan Dhall Hospital
New Delhi, National Capital Territory of Delhi, India
Hero DMC Heart Institute, Dayanand Medical College and Hospital
Ludhiana, Punjab, India
Apollo Research and Innovation
Chennai, Tamil Nadu, India
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)
Pondicherry, Tamil Nadu, India
CARE Nampally
Hyderabad, Telangana, India
Apollo Research & Innovations
Hyderabad, Telangana, India
King George's Medical University, Department of Cardiology
Lucknow, Uttar Pradesh, India
All India Institute of Medical Sciences
New Delhi, , India
Rambam Medical Center
Haifa, , Israel
Assuta Medical Centers
Tel Aviv, , Israel
AORN Dei Colli "V. Monaldi" UOC Cardiologia Università della Campania "L.Vanvitelli"
Napoli, Campania, Italy
Ospedale "G.B. Morgagni - L. Pierantoni" Forli (AUSL della Romagna)
Forlì, Emilia-Romagna, Italy
IRCCS "Casa Sollievo della Sofferenza"
San Giovanni Rotondo, FG, Italy
Policlinico di Monza, Monza MB
Monza, MB, Italy
Humanitas Research Hospital, Rozzano (MI)
Rozzano, Milano, Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, Piedmont, Italy
Cardiology and CCU - Ospedali Riuniti Ancona
Ancona, The Marches, Italy
UO Cardiologia Ospedale SS Cosma e Damiano
Pescia, Tuscany, Italy
Azienda Servizi Sanitaria n.3 Alto Friuli-Collinare-Medio Friuli
Tolmezzo, Udine, Italy
University of Padua- Cardiology Clinic
Padua, Veneto, Italy
Ospedale Regionale Umberto Parini
Aosta, , Italy
Clinica Mediterranea
Naples, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
National Cerebral and Cardiovascular Center
Suita-shi, Osaka, Japan
Saitama Medical University
Hidaka, Saitama, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
Vilnius University Hospital Santariskes Clinic
Vilnius, , Lithuania
Institut Jantung Negara
Kuala Lumpur, Kuala Lumpur, Malaysia
Instituto Mexicano del Seguro Social
Benito Juárez, Mexico City, Mexico
Instituto Nacional de Cardiología "Ignacio Chávez"
Mexico City, Mexico City, Mexico
Cardio Research Hartcentrum OLVG
Amsterdam, North Holland, Netherlands
Radboudumc
Nijmegen, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Waikato Hospital
Hamilton, Waikato Region, New Zealand
Auckland City Hospital
Auckland, , New Zealand
University Clinic of Cardiology
Skopje, Republic of Macedo, North Macedonia
Instituto Neuro Cardiovascular De Las Americas
Miraflores, Lima region, Peru
T.Marciniak Hospital
Wroclaw, Dolny Śląsk, Poland
Department of Coronary Disease, John Paul II Hospital, Jagiellonian University Medical College
Krakow, Maopolskie, Poland
Department of Internal Medicine and Cardiology, Infant Jesus Teaching Hospital, Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Coronary and Structural Heart Diseases Department, Institute of Cardiology
Warsaw, Masovian Voivodeship, Poland
Department of Interventional Cardiology & Angiology, Institute of Cardiology
Warsaw, Masovian Voivodeship, Poland
Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Institute of Cardiology, Warsaw
Warsaw, Mazovian, Poland
University Hospital in Bialystok
Bialystok, Podlaskie Voivodeship, Poland
Medical University of Silesia, School of Medicine with the Division of Dentistry, Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Silesian Center for Heart Diseases
Zabrze, Silesian Voivodeship, Poland
Szpital Kliniczny Przemienienia Pańskiego
Poznan, , Poland
Military Hospital / Medical University
Wroclaw, , Poland
Cardiology Clinic, Medical University in Lodz
Lodz, Łódź Voivodeship, Poland
Hospital de Santa Marta
Lisbon, , Portugal
Santa Maria University Hospital, Cardiology Department, CHLN
Lisbon, , Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
Vila Nova de Gaia, , Portugal
Emergency County Hospital Baia Mare
Baia Mare, , Romania
Emergency Institute of Cardiovascular Diseases ''Prof. Dr. C. C. Iliescu''
Bucharest, , Romania
National Medical Research Center for Cardiovascuar Surgery
Moscow, Gorod Moskva, Russia
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
Novosibirsk, Novosibirsk Oblast, Russia
Federal Almazov North-West Medical Research Centre
Saint Petersburg, , Russia
North-Western State Medical University
Saint Petersburg, , Russia
King AbdulAziz Cardiac Center
Riyadh, Central Province, Saudi Arabia
Institute of Cardiovascular Diseases Vojvodina, Sremska Kamenica, Serbia and Faculty of Medicine, University of Novi Sad
Kamenitz, Vojvodina, Serbia
Clinical Center of Serbia
Belgrade, , Serbia
Faculty of Medicine, University of Belgrade; Cardiology Clinic, Clinical Center of Serbia
Belgrade, , Serbia
University Clinical Hospital Zvezdara
Belgrade, , Serbia
University Hospital Center Bezanijska Kosa
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Clinic for Cardiovascular Diseases, Clinical Center Nis
Niš, , Serbia
National University Heart Center Singapore
Singapore, , Singapore
National Heart Centre Singapore
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Groote Schuur Hospital / University of Cape Town
Cape Town, Western Cape, South Africa
Hospital Clinico Universitario de Santiago
Santiago de Compostela, La Coruna, Spain
Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas, Department of Cardiology. INIBIC A Coruña. CIBER-CV. Universidad de A Coruña, Spain
A Coruña, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital De Bellvitge
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital La Paz. IdiPaz
Madrid, , Spain
HUVA, Hospital Clínico Universitario Virgen De La Arrixaca
Murcia, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Karolinska Institutet at Danderyd Hospital
Stockholm, , Sweden
Uppsala University
Uppsala, , Sweden
Cardiocentro
Lugano, Canton Ticino, Switzerland
Mackay Memorial Hospital
Taipei, , Taiwan
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Meung, Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Belfast Trust
Belfast, Antrim, United Kingdom
Bedford Hospital NHS Trust
Bedford, Bedfordshire, United Kingdom
Luton and Dunstable University Hospital NHS FT
Luton, Berdfordshire, United Kingdom
Papworth Hospital
Cambridge, Cambridgeshire, United Kingdom
Peterborough City Hospital
Peterborough, Cambs, United Kingdom
The James Cook University Hospital, Middlesbrough
Middlesbrough, Cleveland, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom
Dorset County Hospital
Dorchester, Dorset, United Kingdom
The University of Hull/Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom
Broomfield Hospital
Chelmsford, Essex, United Kingdom
Southend University Hospital
Westcliff-on-Sea, Essex, United Kingdom
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom
Blackpool Teaching Hospitals
Blackpool, Lancashire, United Kingdom
The Pennine Acute Hospitals NHS Trust
Oldham, Lancashire, United Kingdom
Northwick Park Hospital Harrow/ Royal Brompton Hospital London
Harrow, Middlesex, United Kingdom
South Eastern Health and Social Care
Belfast, Northern Ireland, United Kingdom
Cardiovascular Research Unit, Craigavon Area Hospital
Craigavon, Northern Ireland, United Kingdom
Nottingham University Hospitals
Nottingham, Notts, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom
University of Glasgow
Clydebank, Strathclyde, United Kingdom
Russells Hall Hospital
Dudley, West Midlands, United Kingdom
Bradford Royal Infirmary
Bradford, West Yorkshire, United Kingdom
Pinderfields Hospital
Wakefield, West Yorkshire, United Kingdom
University College London Hospitals NHS Foundation Trust/Barts Health NHS Trust
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
King's College NHS Foundation Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Central Manchester University Hospital
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Maron DJ, Stone GW, Berman DS, Mancini GB, Scott TA, Byrne DW, Harrell FE Jr, Shaw LJ, Hachamovitch R, Boden WE, Weintraub WS, Spertus JA. Is cardiac catheterization necessary before initial management of patients with stable ischemic heart disease? Results from a Web-based survey of cardiologists. Am Heart J. 2011 Dec;162(6):1034-1043.e13. doi: 10.1016/j.ahj.2011.09.001.
Phillips LM, Hachamovitch R, Berman DS, Iskandrian AE, Min JK, Picard MH, Kwong RY, Friedrich MG, Scherrer-Crosbie M, Hayes SW, Sharir T, Gosselin G, Mazzanti M, Senior R, Beanlands R, Smanio P, Goyal A, Al-Mallah M, Reynolds H, Stone GW, Maron DJ, Shaw LJ. Lessons learned from MPI and physiologic testing in randomized trials of stable ischemic heart disease: COURAGE, BARI 2D, FAME, and ISCHEMIA. J Nucl Cardiol. 2013 Dec;20(6):969-75. doi: 10.1007/s12350-013-9773-4.
ISCHEMIA Trial Research Group; Maron DJ, Hochman JS, O'Brien SM, Reynolds HR, Boden WE, Stone GW, Bangalore S, Spertus JA, Mark DB, Alexander KP, Shaw L, Berger JS, Ferguson TB Jr, Williams DO, Harrington RA, Rosenberg Y. International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design. Am Heart J. 2018 Jul;201:124-135. doi: 10.1016/j.ahj.2018.04.011. Epub 2018 Apr 21.
Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Alexander KP, Senior R, Boden WE, Stone GW, Goodman SG, Lopes RD, Lopez-Sendon J, White HD, Maggioni AP, Shaw LJ, Min JK, Picard MH, Berman DS, Chaitman BR, Mark DB, Spertus JA, Cyr DD, Bhargava B, Ruzyllo W, Wander GS, Chernyavskiy AM, Rosenberg YD, Maron DJ; ISCHEMIA Research Group. Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial. JAMA Cardiol. 2019 Mar 1;4(3):273-286. doi: 10.1001/jamacardio.2019.0014.
Ikemura N, Jones PG, Fu Z, Chan PS, Sherrod CF 4th, Arnold SV, Cohen DJ, Mark DB, Maron DJ, Hochman JS, Spertus JA; ISCHEMIA Research Group. Trajectories of Angina After Initial Invasive vs Conservative Strategy for Chronic Coronary Disease. J Am Coll Cardiol. 2025 Sep 16;86(11):782-793. doi: 10.1016/j.jacc.2025.06.044.
Huded CP, Spertus JA, Jones PG, O'Brien SM, Mark DB, Bangalore S, Stone GW, Williams DO, White HD, Boden WE, Reynolds HR, Hochman JS, Maron DJ; ISCHEMIA Research Group. Health Status Outcomes With Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting in ISCHEMIA. Circulation. 2025 Sep 23;152(12):846-858. doi: 10.1161/CIRCULATIONAHA.125.073591. Epub 2025 Sep 5.
Shaw LJ, Phillips LM, Leipsic J, Broderick S, Mieres JH, Marwick TH, Friedrich MG, Miller T, Lopes RD, Chow B, Cerci R, Blankstein R, DiCarli M, Maron DJ, Hochman JS, Alexander KP, Stone GW, O'Brien S, Chaitman BR, Kwong RY, Picard MH, Berman DS, Reynolds HR; ISCHEMIA Research Group. Comparative Prognosis by Stress ECG and Stress Imaging: Results From the ISCHEMIA Trial. JACC Cardiovasc Imaging. 2025 Sep;18(9):943-955. doi: 10.1016/j.jcmg.2025.03.016. Epub 2025 Jul 9.
White HD, O'Brien SM, Boden WE, Fremes SE, Bangalore S, Reynolds HR, Stone GW, Ali ZA, Parakh N, Lopez-Sendon JL, Wang Y, Chen YQ, Mark DB, Chaitman BR, Spertus JA, Maron DJ, Hochman JS; ISCHEMIA Research Group.. Use of coronary artery bypass graft surgery and percutaneous coronary intervention and associated outcomes in the ISCHEMIA trial. Am Heart J. 2025 Nov;289:78-94. doi: 10.1016/j.ahj.2025.05.009. Epub 2025 May 20.
Lerner JB, Pleasure M, Min JK, Picard MH, Peteiro J, Senior R, Celutkiene J, Shapiro MD, Pellikka PA, de Quadros AS, Chow BJW, Tamis-Holland JE, Rodriguez F, Fleg JL, Maron DJ, Hochman JS, Reynolds HR; CIAO-ISCHEMIA Research Group. Quantitative Coronary Artery Plaque Parameters and Severity of Ischemia in Patients With INOCA. Circ Cardiovasc Imaging. 2025 Apr;18(4):e017367. doi: 10.1161/CIRCIMAGING.124.017367. Epub 2025 Mar 31. No abstract available.
Bangalore S, Mancini GBJ, Leipsic J, Budoff MJ, Xu Y, Anthopolos R, Brilakis ES, Dwivedi A, Spertus JA, Jones PG, Cho YJ, Mark DB, Hague CJ, Min JK, Reynolds HR, Elghamaz A, Nair RG, Mavromatis K, Gosselin G, Banerjee S, Pejkov H, Lindsay S, Grantham JA, Williams DO, Stone GW, O'Brien SM, Hochman JS, Maron DJ; ISCHEMIA Research Group. Invasive vs Conservative Management of Patients With Chronic Total Occlusion: Results From the ISCHEMIA Trial. J Am Coll Cardiol. 2025 Apr 1;85(12):1335-1349. doi: 10.1016/j.jacc.2025.01.029.
Maron DJ, Newman JD, Anthopolos R, Lu Y, Stevens S, Boden WE, Mavromatis K, Linefsky J, Nair RG, Bockeria O, Gosselin G, Perna GP, Demchenko E, Foo D, Shapiro MD, Champagne MA, Ballantyne C, McCullough P, Lopez-Sendon JL, Rockhold F, Harrell F, Rosenberg Y, Stone GW, Bangalore S, Reynolds HR, Spertus JA, Hochman JS; ISCHEMIA Research Group. Guideline-Directed Medical Therapy and Outcomes in the ISCHEMIA Trial. J Am Coll Cardiol. 2025 Apr 1;85(12):1317-1331. doi: 10.1016/j.jacc.2025.01.028.
Slater J, Maron DJ, Jones PG, Bangalore S, Reynolds HR, Fu Z, Stone GW, Kirby R, Hochman JS, Spertus JA; ISCHEMIA Research Group. Evaluating the Appropriate Use Criteria for Coronary Revascularization in Stable Ischemic Heart Disease Using Randomized Data From the ISCHEMIA Trial. Circ Cardiovasc Qual Outcomes. 2025 Mar;18(3):e010849. doi: 10.1161/CIRCOUTCOMES.124.010849. Epub 2025 Feb 26.
Hausvater A, Anthopolos R, Seltzer A, Spruill TM, Spertus JA, Peteiro J, Lopez-Sendon JL, Celutkiene J, Demchenko EA, Kedev S, Beleslin BD, Sidhu MS, Grodzinsky A, Fleg JL, Maron DJ, Hochman JS, Reynolds HR; CIAO-ISCHEMIA Research Group. Sex Differences in Psychosocial Factors and Angina in Patients With Chronic Coronary Disease. J Am Heart Assoc. 2025 Mar 4;14(5):e037909. doi: 10.1161/JAHA.124.037909. Epub 2025 Feb 25.
Reynolds HR, Page CB, Shaw LJ, Berman DS, Chaitman BR, Picard MH, Kwong RY, Min JK, Leipsic J, Mancini GBJ, Budoff MJ, Hague CJ, Senior R, Szwed H, Bhargava B, Celutkiene J, Gadkari M, Bainey KR, Doerr R, Ramos RB, Ong P, Naik SR, Steg PG, Goetschalckx K, Chow BJW, Scherrer-Crosbie M, Phillips L, Mark DB, Spertus JA, Alexander KP, O'Brien SM, Boden WE, Bangalore S, Stone GW, Maron DJ, Hochman JS; ISCHEMIA Research Group. Relationship Between Severity of Ischemia and Coronary Artery Disease for Different Stress Test Modalities in the ISCHEMIA Trial. Circ Cardiovasc Interv. 2024 Dec;17(12):e013743. doi: 10.1161/CIRCINTERVENTIONS.123.013743. Epub 2024 Dec 17.
Bangalore S, Rhodes G, Maron DJ, Anthopolos R, O'Brien SM, Jones PG, Mark DB, Reynolds HR, Spertus JA, Stone GW, White HD, Xu Y, Fremes SE, Hochman JS, Ischemia Research Group OBOT. Outcomes with revascularisation versus conservative management of participants with 3-vessel coronary artery disease in the ISCHEMIA trial. EuroIntervention. 2024 Oct 21;20(20):e1276-e1287. doi: 10.4244/EIJ-D-24-00240.
Ikemura N, Spertus JA, Nguyen D, Fu Z, Jones PG, Reynolds HR, Bangalore S, Bhargava B, Senior R, Elghamaz A, Goodman SG, Lopes RD, Pracon R, Lopez-Sendon J, Maggioni AP, Kohsaka S, Roth GA, White HD, Mavromatis K, Boden WE, Rodriguez F, Hochman JS, Maron DJ; ISCHEMIA Research Group. International Variation in Health Status Benefits in Patients Undergoing Initial Invasive Versus Conservative Management for Chronic Coronary Disease: Insights From the ISCHEMIA Trial. Circ Cardiovasc Qual Outcomes. 2024 Oct;17(10):e010534. doi: 10.1161/CIRCOUTCOMES.123.010534. Epub 2024 Sep 20.
Jorda A, Pecho T, Horvath LC, Nishani E, Bull LE, Bergmann F, Nitsche C, Zeitlinger M, Jilma B, Gelbenegger G. Association of Electrocardiogram Findings With Clinical Outcomes in Patients With Chronic Coronary Syndrome: An Analysis of the ISCHEMIA Trials. Am J Med. 2025 Jan;138(1):61-69.e3. doi: 10.1016/j.amjmed.2024.09.007. Epub 2024 Sep 14.
Fleg JL, Huang Z, Reynolds HR, Shaw LJ, Chaitman BR, O'Brien SM, Berstein L, Peteiro J, Smanio PEP, Wander GS, Berger JS, Berman DS, Picard MH, Kwong RY, Min JK, Phillips LM, Bangalore S, Maron DJ, Hochman JS; ISCHEMIA Research Group. Ischemia Severity, Coronary Artery Disease Extent, and Exercise Capacity in ISCHEMIA. Circulation. 2024 Jul 9;150(2):165-167. doi: 10.1161/CIRCULATIONAHA.123.066980. Epub 2024 Jul 8. No abstract available.
Jorda A, Hengstenberg C, Lang IM, Kautzky-Willer A, Harreiter J, Zeitlinger M, Jilma B, Gelbenegger G. Association of prediabetes with clinical outcomes in patients with chronic coronary syndrome: a post hoc analysis of the ISCHEMIA and ISCHEMIA-CKD trials. Cardiovasc Diabetol. 2024 May 20;23(1):176. doi: 10.1186/s12933-024-02232-z.
Pracon R, Spertus JA, Broderick S, Bangalore S, Rockhold FW, Ruzyllo W, Demchenko E, Nageh T, Grossman GB, Mavromatis K, Manjunath CN, Smanio PEP, Stone GW, Mancini GBJ, Boden WE, Newman JD, Reynolds HR, Hochman JS, Maron DJ; ISCHEMIA Research Group. Factors Associated With Coronary Angiography Performed Within 6 Months of Randomization to the Conservative Strategy in the ISCHEMIA Trial. Circ Cardiovasc Interv. 2024 Jun;17(6):e013435. doi: 10.1161/CIRCINTERVENTIONS.123.013435. Epub 2024 Apr 17.
Arnold SV, Jones PG, Maron DJ, Cohen DJ, Mark DB, Reynolds HR, Bangalore S, Chen J, Newman JD, Harrington RA, Stone GW, Hochman JS, Spertus JA; ISCHEMIA Research Group. Variation in Health Status With Invasive vs Conservative Management of Chronic Coronary Disease. J Am Coll Cardiol. 2024 Apr 16;83(15):1353-1366. doi: 10.1016/j.jacc.2024.02.019.
Reynolds HR, Cyr DD, Merz CNB, Shaw LJ, Chaitman BR, Boden WE, Alexander KP, Rosenberg YD, Bangalore S, Stone GW, Held C, Spertus J, Goetschalckx K, Bockeria O, Newman JD, Berger JS, Elghamaz A, Lopes RD, Min JK, Berman DS, Picard MH, Kwong RY, Harrington RA, Thomas B, O'Brien SM, Maron DJ, Hochman JS; ISCHEMIA Research Group *. Sex Differences in Revascularization, Treatment Goals, and Outcomes of Patients With Chronic Coronary Disease: Insights From the ISCHEMIA Trial. J Am Heart Assoc. 2024 Mar 5;13(5):e029850. doi: 10.1161/JAHA.122.029850. Epub 2024 Feb 27.
Mavromatis K, Jones PG, Ali ZA, Stone GW, Rhodes GM, Bangalore S, O'Brien S, Genereux P, Horst J, Dressler O, Goodman S, Alexander K, Mathew A, Chen J, Bhargava B, Uxa A, Boden WE, Mark DB, Reynolds HR, Maron DJ, Hochman JS, Spertus JA; ISCHEMIA Research Group. Complete Revascularization and Angina-Related Health Status in the ISCHEMIA Trial. J Am Coll Cardiol. 2023 Jul 25;82(4):295-313. doi: 10.1016/j.jacc.2023.05.025.
Stone GW, Ali ZA, O'Brien SM, Rhodes G, Genereux P, Bangalore S, Mavromatis K, Horst J, Dressler O, Poh KK, Nath RK, Moorthy N, Witkowski A, Dwivedi SK, Bockeria O, Chen J, Smanio PEP, Picard MH, Chaitman BR, Berman DS, Shaw LJ, Boden WE, White HD, Fremes SE, Rosenberg Y, Reynolds HR, Spertus JA, Hochman JS, Maron DJ; ISCHEMIA Research Group. Impact of Complete Revascularization in the ISCHEMIA Trial. J Am Coll Cardiol. 2023 Sep 19;82(12):1175-1188. doi: 10.1016/j.jacc.2023.06.015. Epub 2023 Jul 17.
Nguyen DD, Spertus JA, Alexander KP, Newman JD, Dodson JA, Jones PG, Stevens SR, O'Brien SM, Gamma R, Perna GP, Garg P, Vitola JV, Chow BJW, Vertes A, White HD, Smanio PEP, Senior R, Held C, Li J, Boden WE, Mark DB, Reynolds HR, Bangalore S, Chan PS, Stone GW, Arnold SV, Maron DJ, Hochman JS; ISCHEMIA Research Group. Health Status and Clinical Outcomes in Older Adults With Chronic Coronary Disease: The ISCHEMIA Trial. J Am Coll Cardiol. 2023 May 2;81(17):1697-1709. doi: 10.1016/j.jacc.2023.02.048.
Gala ABE, Curzen N. Is There Still a Place for Revascularisation in the Management of Stable Coronary Artery Disease Following the ISCHEMIA Trial? Heart Int. 2020 Aug 8;14(1):13-15. doi: 10.17925/HI.2020.14.1.13. eCollection 2020.
Reynolds HR, Diaz A, Cyr DD, Shaw LJ, Mancini GBJ, Leipsic J, Budoff MJ, Min JK, Hague CJ, Berman DS, Chaitman BR, Picard MH, Hayes SW, Scherrer-Crosbie M, Kwong RY, Lopes RD, Senior R, Dwivedi SK, Miller TD, Chow BJW, de Silva R, Stone GW, Boden WE, Bangalore S, O'Brien SM, Hochman JS, Maron DJ; ISCHEMIA Research Group. Ischemia With Nonobstructive Coronary Arteries: Insights From the ISCHEMIA Trial. JACC Cardiovasc Imaging. 2023 Jan;16(1):63-74. doi: 10.1016/j.jcmg.2022.06.015. Epub 2022 Sep 14.
Garcia RA, Spertus JA, Benton MC, Jones PG, Mark DB, Newman JD, Bangalore S, Boden WE, Stone GW, Reynolds HR, Hochman JS, Maron DJ; ISCHEMIA Research Group. Association of Medication Adherence With Health Outcomes in the ISCHEMIA Trial. J Am Coll Cardiol. 2022 Aug 23;80(8):755-765. doi: 10.1016/j.jacc.2022.05.045.
Bangalore S, Spertus JA, Stevens SR, Jones PG, Mancini GBJ, Leipsic J, Reynolds HR, Budoff MJ, Hague CJ, Min JK, Boden WE, O'Brien SM, Harrington RA, Berger JS, Senior R, Peteiro J, Pandit N, Bershtein L, de Belder MA, Szwed H, Doerr R, Monti L, Alfakih K, Hochman JS, Maron DJ; ISCHEMIA Research Group. Outcomes With Intermediate Left Main Disease: Analysis From the ISCHEMIA Trial. Circ Cardiovasc Interv. 2022 Apr;15(4):e010925. doi: 10.1161/CIRCINTERVENTIONS.121.010925. Epub 2022 Apr 12.
Mark DB, Spertus JA, Bigelow R, Anderson S, Daniels MR, Anstrom KJ, Baloch KN, Cohen DJ, Held C, Goodman SG, Bangalore S, Cyr D, Reynolds HR, Alexander KP, Rosenberg Y, Stone GW, Maron DJ, Hochman JS; ISCHEMIA Research Group. Comprehensive Quality-of-Life Outcomes With Invasive Versus Conservative Management of Chronic Coronary Disease in ISCHEMIA. Circulation. 2022 Apr 26;145(17):1294-1307. doi: 10.1161/CIRCULATIONAHA.121.057363. Epub 2022 Mar 9.
Senior R, Reynolds HR, Min JK, Berman DS, Picard MH, Chaitman BR, Shaw LJ, Page CB, Govindan SC, Lopez-Sendon J, Peteiro J, Wander GS, Drozdz J, Marin-Neto J, Selvanayagam JB, Newman JD, Thuaire C, Christopher J, Jang JJ, Kwong RY, Bangalore S, Stone GW, O'Brien SM, Boden WE, Maron DJ, Hochman JS; ISCHEMIA Research Group. Predictors of Left Main Coronary Artery Disease in the ISCHEMIA Trial. J Am Coll Cardiol. 2022 Feb 22;79(7):651-661. doi: 10.1016/j.jacc.2021.11.052.
Newman JD, Anthopolos R, Mancini GBJ, Bangalore S, Reynolds HR, Kunichoff DF, Senior R, Peteiro J, Bhargava B, Garg P, Escobedo J, Doerr R, Mazurek T, Gonzalez-Juanatey J, Gajos G, Briguori C, Cheng H, Vertes A, Mahajan S, Guzman LA, Keltai M, Maggioni AP, Stone GW, Berger JS, Rosenberg YD, Boden WE, Chaitman BR, Fleg JL, Hochman JS, Maron DJ. Outcomes of Participants With Diabetes in the ISCHEMIA Trials. Circulation. 2021 Oct 26;144(17):1380-1395. doi: 10.1161/CIRCULATIONAHA.121.054439. Epub 2021 Sep 15.
Lopez-Sendon JL, Cyr DD, Mark DB, Bangalore S, Huang Z, White HD, Alexander KP, Li J, Nair RG, Demkow M, Peteiro J, Wander GS, Demchenko EA, Gamma R, Gadkari M, Poh KK, Nageh T, Stone PH, Keltai M, Sidhu M, Newman JD, Boden WE, Reynolds HR, Chaitman BR, Hochman JS, Maron DJ, O'Brien SM. Effects of initial invasive vs. initial conservative treatment strategies on recurrent and total cardiovascular events in the ISCHEMIA trial. Eur Heart J. 2022 Jan 13;43(2):148-149. doi: 10.1093/eurheartj/ehab509.
Reynolds HR, Shaw LJ, Min JK, Page CB, Berman DS, Chaitman BR, Picard MH, Kwong RY, O'Brien SM, Huang Z, Mark DB, Nath RK, Dwivedi SK, Smanio PEP, Stone PH, Held C, Keltai M, Bangalore S, Newman JD, Spertus JA, Stone GW, Maron DJ, Hochman JS. Outcomes in the ISCHEMIA Trial Based on Coronary Artery Disease and Ischemia Severity. Circulation. 2021 Sep 28;144(13):1024-1038. doi: 10.1161/CIRCULATIONAHA.120.049755. Epub 2021 Sep 9.
White HD, O'Brien SM, Alexander KP, Boden WE, Bangalore S, Li J, Manjunath CN, Lopez-Sendon JL, Peteiro J, Gosselin G, Berger JS, Maggioni AP, Reynolds HR, Hochman JS, Maron DJ. Comparison of Days Alive Out of Hospital With Initial Invasive vs Conservative Management: A Prespecified Analysis of the ISCHEMIA Trial. JAMA Cardiol. 2021 Sep 1;6(9):1023-1031. doi: 10.1001/jamacardio.2021.1651.
Chaitman BR, Alexander KP, Cyr DD, Berger JS, Reynolds HR, Bangalore S, Boden WE, Lopes RD, Demkow M, Piero Perna G, Riezebos RK, McFalls EO, Banerjee S, Bagai A, Gosselin G, O'Brien SM, Rockhold FW, Waters DD, Thygesen KA, Stone GW, White HD, Maron DJ, Hochman JS; ISCHEMIA Research Group. Myocardial Infarction in the ISCHEMIA Trial: Impact of Different Definitions on Incidence, Prognosis, and Treatment Comparisons. Circulation. 2021 Feb 23;143(8):790-804. doi: 10.1161/CIRCULATIONAHA.120.047987. Epub 2020 Dec 3.
Lopes RD, Alexander KP, Stevens SR, Reynolds HR, Stone GW, Pina IL, Rockhold FW, Elghamaz A, Lopez-Sendon JL, Farsky PS, Chernyavskiy AM, Diaz A, Phaneuf D, De Belder MA, Ma YT, Guzman LA, Khouri M, Sionis A, Hausenloy DJ, Doerr R, Selvanayagam JB, Maggioni AP, Hochman JS, Maron DJ. Initial Invasive Versus Conservative Management of Stable Ischemic Heart Disease in Patients With a History of Heart Failure or Left Ventricular Dysfunction: Insights From the ISCHEMIA Trial. Circulation. 2020 Nov 3;142(18):1725-1735. doi: 10.1161/CIRCULATIONAHA.120.050304. Epub 2020 Aug 29.
Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
Spertus JA, Jones PG, Maron DJ, O'Brien SM, Reynolds HR, Rosenberg Y, Stone GW, Harrell FE Jr, Boden WE, Weintraub WS, Baloch K, Mavromatis K, Diaz A, Gosselin G, Newman JD, Mavromichalis S, Alexander KP, Cohen DJ, Bangalore S, Hochman JS, Mark DB; ISCHEMIA Research Group. Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1408-1419. doi: 10.1056/NEJMoa1916370. Epub 2020 Mar 30.
Reynolds HR, Shaw LJ, Min JK, Spertus JA, Chaitman BR, Berman DS, Picard MH, Kwong RY, Bairey-Merz CN, Cyr DD, Lopes RD, Lopez-Sendon JL, Held C, Szwed H, Senior R, Gosselin G, Nair RG, Elghamaz A, Bockeria O, Chen J, Chernyavskiy AM, Bhargava B, Newman JD, Hinic SB, Jaroch J, Hoye A, Berger J, Boden WE, O'Brien SM, Maron DJ, Hochman JS; ISCHEMIA Research Group. Association of Sex With Severity of Coronary Artery Disease, Ischemia, and Symptom Burden in Patients With Moderate or Severe Ischemia: Secondary Analysis of the ISCHEMIA Randomized Clinical Trial. JAMA Cardiol. 2020 Jul 1;5(7):773-786. doi: 10.1001/jamacardio.2020.0822.
Azevedo DFC, Lima EG, Ribeiro MOL, Linhares Filho JPP, Serrano Junior CV. Critical analysis of the classic indications for myocardial revascularization. Rev Assoc Med Bras (1992). 2019 Mar;65(3):319-325. doi: 10.1590/1806-9282.65.3.319. Epub 2019 Apr 11.
Shaw LJ, Xie JX, Phillips LM, Goyal A, Reynolds HR, Berman DS, Picard MH, Bhargava B, Devlin G, Chaitman BR. Optimising diagnostic accuracy with the exercise ECG: opportunities for women and men with stable ischaemic heart disease. Heart Asia. 2016 Jun 1;8(2):1-7. doi: 10.1136/heartasia-2016-010736. eCollection 2016.
Kataoka A, Scherrer-Crosbie M, Senior R, Gosselin G, Phaneuf D, Guzman G, Perna G, Lara A, Kedev S, Mortara A, El-Hajjar M, Shaw LJ, Reynolds HR, Picard MH. The value of core lab stress echocardiography interpretations: observations from the ISCHEMIA Trial. Cardiovasc Ultrasound. 2015 Dec 18;13:47. doi: 10.1186/s12947-015-0043-2.
Stone GW, Hochman JS, Williams DO, Boden WE, Ferguson TB Jr, Harrington RA, Maron DJ. Medical Therapy With Versus Without Revascularization in Stable Patients With Moderate and Severe Ischemia: The Case for Community Equipoise. J Am Coll Cardiol. 2016 Jan 5;67(1):81-99. doi: 10.1016/j.jacc.2015.09.056. Epub 2015 Nov 23.
Wasilewski J, Polonski L, Lekston A, Osadnik T, Regula R, Bujak K, Kurek A. Who is eligible for randomized trials? A comparison between the exclusion criteria defined by the ISCHEMIA trial and 3102 real-world patients with stable coronary artery disease undergoing stent implantation in a single cardiology center. Trials. 2015 Sep 15;16:411. doi: 10.1186/s13063-015-0934-4.
Provided Documents
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Document Type: Study Protocol: Study Protocol v.1.0
Document Type: Study Protocol: Study Protocol v.2.0
Document Type: Study Protocol: Protocol Addendum
Document Type: Statistical Analysis Plan
Related Links
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Main Website for ISCHEMIA Trial
Coronary Artery Bypass Surgery
Coronary Artery Disease
Heart Diseases
ISCHEMIA Trial Update
Other Identifiers
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11-00498
Identifier Type: -
Identifier Source: org_study_id
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