Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
406 participants
OBSERVATIONAL
2016-05-19
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Management of Acute Cardiogenic Shock at the New Brunswick Heart Centre
NCT05414643
Clinical Echocardiography and S' Wave for Early Recognition of Acute Coronary Syndrome in the Emergency Department, A Prospective Study
NCT06860997
Development of an Evidenced-Based Tool for Prediction of Sudden Death in Patients With Non-Ischemic Cardiomyopathy
NCT02657967
Evaluation of Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction
NCT02641184
Microvascular Dysfunction in Acute Myocardial Infarction (AMI) and Its Relation to Outcome
NCT01538303
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
With the FDA approval of Impella (Abiomed, Danvers, MA) in AMICS, a powerful new tool has become available for hemodynamic support. Impella is a transcatheter axial flow pump, delivered percutaneous, with the ability to provide 2.5 to 4.0 liters/minute of forward flow. The device should provide sufficient forward cardiac flow to support vital organs in the majority of patients who present with AMICS. Since Impella is the only percutaneous temporary ventricular support device approved as safe and effective for use in AMICS, the use of the device has steadily grown. Unfortunately, there is little data available to providers as to the best practice patterns associated with the delivery and use of Impella in AMICS.
Using the most up-to-date research, a treatment algorithm for AMICS was developed and subsequently implemented as a quality improvement initiative throughout southeast Michigan. Patient information was gathered by each of the sites and collected in a retrospective registry. Outcomes and results were shared during quarterly meetings and concluded with a 41-patient pilot feasibility study. This initial pilot study revealed a 76% survival to discharge, a significant improvement compared to prior historical controls.
Given the promising outcomes, leaders from around the world have implemented the treatment algorithm in their local clinical practices with similar results. The investigators have therefore launched the National Cardiogenic Shock Initiative (NCSI). The aim of the NCSI is to bring together experienced centers across the nation who are experts in mechanical reperfusion therapies and have a large experience with the use of mechanical circulatory support devices to systematize care in AMICS.
Our goal is to dramatically decrease the duration patients remain in cardiogenic shock and attempt to decrease total usage and duration of vasopressors and ionotropic agents. The investigators aim to further demonstrate that rapid delivery of mechanical circulatory support will improve hemodynamics, reverse the spiraling neuro-hormonal cascade associated with cardiogenic shock, allowing clinicians to decrease use of vasopressors and inotropic agents and ultimately improve survival.
Healthcare systems that have agreed to adopt the NCSI treatment algorithm are being asked to participate in this prospective registry so that patient outcomes can be analyzed. Participating investigators will be asked to voluntarily provide data from patients completing the treatment algorithm to be included in the NCSI Registry.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Cardiogenic shock is defined as the presence of at least two of the following:
1. Hypotension (systolic blood pressure ≤90 mm Hg, or inotropes/vasopressors to maintain systolic blood pressure ≥90 mmHg)
2. Signs of end organ hypoperfusion (cool extremities, oliguria or anuria, or elevated lactate levels)
3. Hemodynamic criteria represented by a cardiac index of \<2.2 L/min/m2 or a cardiac power output ≤0.6 watts.
3. Patient is supported with an Impella
4. Patient undergoes PCI
Exclusion Criteria
2. Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes
3. IABP placed prior to Impella
4. Septic, anaphylactic, hemorrhagic, and neurologic causes of shock
5. Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
6. Active bleeding for which mechanical circulatory support is contraindicated
7. Recent major surgery for which mechanical circulatory support is contraindicated
8. Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
9. Known left ventricular thrombus for which mechanical circulatory support is contraindicated
10. Mechanical aortic prosthetic valve
11. Contraindication to intravenous systemic anticoagulation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abiomed Inc.
INDUSTRY
Chiesi Farmaceutici S.p.A.
INDUSTRY
Henry Ford Health System
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
William W. O'Neill
Medical Director, Center for Structural Heart Disease
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
William W O'Neill, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Babar Basir, DO
Role: STUDY_DIRECTOR
Henry Ford Health System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UAB Hospital
Birmingham, Alabama, United States
Washington Regional Medical Center
Fayetteville, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Northwest Medical Center - Springdale
Springdale, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
St. Joseph Hospital Orange
Orange, California, United States
Mercy General Hospital
Sacramento, California, United States
UCLA Medical Center, Santa Monica
Santa Monica, California, United States
St. Anthony Hospital
Lakewood, Colorado, United States
Stamford Hospital
Stamford, Connecticut, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
North Florida Regional Medical Center
Gainesville, Florida, United States
Palmetto General Hospital
Hialeah, Florida, United States
Orange Park Medical Center
Jacksonville, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Elmhurst Hospital
Elmhurst, Illinois, United States
Edward Hospital
Naperville, Illinois, United States
Iowa Heart Center at Mercy Medical Center
Des Moines, Iowa, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
KentuckyOne Health Saint Joseph Hospital
Lexington, Kentucky, United States
KentuckyOne Health Jewish Hospital
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Macomb Hospital
Clinton Township, Michigan, United States
DMC Heart Hospital
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Ascension St. John Hospital
Detroit, Michigan, United States
Spectrum Health Fred and Lena Meijer Heart Center
Grand Rapids, Michigan, United States
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States
Beaumont Hospital, Troy
Troy, Michigan, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Research Medical Center
Kansas City, Missouri, United States
SSM Health St. Louis University Hospital
St Louis, Missouri, United States
CHI Health Nebraska Heart
Lincoln, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Englewood Hospital
Englewood, New Jersey, United States
Hackensack Meridian Health Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Presbyterian Hospital
Albuquerque, New Mexico, United States
San Juan Regional Medical Center
Farmington, New Mexico, United States
Buffalo General Medical Center
Buffalo, New York, United States
Mercy Hospital of Buffalo
Buffalo, New York, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
PeaceHealth Sacred Heart Medical Center at Riverbend
Springfield, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States
Excela Westmoreland Regional Hospital
Greensburg, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
North Knoxville Medical Center
Knoxville, Tennessee, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, United States
Physicians Regional Medical Center
Knoxville, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Parkwest Regional Medical Center
Knoxville, Tennessee, United States
Turkey Creek Medical Center
Knoxville, Tennessee, United States
Methodist University Hospital
Memphis, Tennessee, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
Methodist Medical Center
Oak Ridge, Tennessee, United States
Heart Hospital of Austin
Austin, Texas, United States
Texas Health Presbyterian Hospital Dallas
Dallas, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
Brooke Army Medical Center
San Antonio, Texas, United States
UVA University Hospital
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
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.
O'Neill W, Basir M, Dixon S, Patel K, Schreiber T, Almany S. Feasibility of Early Mechanical Support During Mechanical Reperfusion of Acute Myocardial Infarct Cardiogenic Shock. JACC Cardiovasc Interv. 2017 Mar 27;10(6):624-625. doi: 10.1016/j.jcin.2017.01.014. No abstract available.
Basir MB, Schreiber TL, Grines CL, Dixon SR, Moses JW, Maini BS, Khandelwal AK, Ohman EM, O'Neill WW. Effect of Early Initiation of Mechanical Circulatory Support on Survival in Cardiogenic Shock. Am J Cardiol. 2017 Mar 15;119(6):845-851. doi: 10.1016/j.amjcard.2016.11.037. Epub 2016 Dec 18.
Basir MB, Schreiber T, Dixon S, Alaswad K, Patel K, Almany S, Khandelwal A, Hanson I, George A, Ashbrook M, Blank N, Abdelsalam M, Sareen N, Timmis SBH, O'Neill Md WW. Feasibility of early mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: The Detroit cardiogenic shock initiative. Catheter Cardiovasc Interv. 2018 Feb 15;91(3):454-461. doi: 10.1002/ccd.27427. Epub 2017 Dec 20.
Goldberg RJ, Makam RC, Yarzebski J, McManus DD, Lessard D, Gore JM. Decade-Long Trends (2001-2011) in the Incidence and Hospital Death Rates Associated with the In-Hospital Development of Cardiogenic Shock after Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2016 Mar;9(2):117-25. doi: 10.1161/CIRCOUTCOMES.115.002359. Epub 2016 Feb 16.
Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S, Jain D, Gotsis W, Ahmed A, Frishman WH, Fonarow GC. Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States. J Am Heart Assoc. 2014 Jan 13;3(1):e000590. doi: 10.1161/JAHA.113.000590.
Hochman JS, Sleeper LA, White HD, Dzavik V, Wong SC, Menon V, Webb JG, Steingart R, Picard MH, Menegus MA, Boland J, Sanborn T, Buller CE, Modur S, Forman R, Desvigne-Nickens P, Jacobs AK, Slater JN, LeJemtel TH; SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. One-year survival following early revascularization for cardiogenic shock. JAMA. 2001 Jan 10;285(2):190-2. doi: 10.1001/jama.285.2.190.
Bainey KR, Armstrong PW. Transatlantic Comparison of ST-Segment Elevation Myocardial Infarction Guidelines: Insights From the United States and Europe. J Am Coll Cardiol. 2016 Jan 19;67(2):216-229. doi: 10.1016/j.jacc.2015.11.010. Epub 2015 Dec 23.
Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.
Killip T 3rd, Kimball JT. Treatment of myocardial infarction in a coronary care unit. A two year experience with 250 patients. Am J Cardiol. 1967 Oct;20(4):457-64. doi: 10.1016/0002-9149(67)90023-9. No abstract available.
Stretch R, Sauer CM, Yuh DD, Bonde P. National trends in the utilization of short-term mechanical circulatory support: incidence, outcomes, and cost analysis. J Am Coll Cardiol. 2014 Oct 7;64(14):1407-15. doi: 10.1016/j.jacc.2014.07.958.
Basir MB, Kapur NK, Patel K, Salam MA, Schreiber T, Kaki A, Hanson I, Almany S, Timmis S, Dixon S, Kolski B, Todd J, Senter S, Marso S, Lasorda D, Wilkins C, Lalonde T, Attallah A, Larkin T, Dupont A, Marshall J, Patel N, Overly T, Green M, Tehrani B, Truesdell AG, Sharma R, Akhtar Y, McRae T 3rd, O'Neill B, Finley J, Rahman A, Foster M, Askari R, Goldsweig A, Martin S, Bharadwaj A, Khuddus M, Caputo C, Korpas D, Cawich I, McAllister D, Blank N, Alraies MC, Fisher R, Khandelwal A, Alaswad K, Lemor A, Johnson T, Hacala M, O'Neill WW; National Cardiogenic Shock Initiative Investigators. Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1173-1183. doi: 10.1002/ccd.28307. Epub 2019 Apr 25.
Lorusso R. First Myocardial Resting or First Myocardial Revascularization for Cardiogenic Shock After Acute Myocardial Infarction-Related Cardiac Arrest? Still a Hamlet Dilemma...Now, With Some More Clues.... Crit Care Med. 2021 Jun 1;49(6):999-1000. doi: 10.1097/CCM.0000000000004932. No abstract available.
Lemor A, Basir MB, Gorgis S, Todd J, Marso S, Gelormini J, Akhtar Y, Baker J, Chahin J, Abdul-Waheed M, Thukral N, O'Neill W. Impact of Age in Acute Myocardial Infarction Cardiogenic Shock: Insights From the National Cardiogenic Shock Initiative. Crit Pathw Cardiol. 2021 Sep 1;20(3):163-167. doi: 10.1097/HPC.0000000000000255.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Related Links
Access external resources that provide additional context or updates about the study.
National Cardiogenic Shock Initiative Website - Henry Ford Hospital
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
National CSI
Identifier Type: OTHER
Identifier Source: secondary_id
NCSI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.