Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
500 participants
OBSERVATIONAL
2022-09-14
2032-12-31
Brief Summary
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Detailed Description
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The Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire (Abbott, Abbott Park, IL) are a device combination consisting of a physiology wire with wireless transmitter (Wi-Box), CoroHub Receiver, and CoroFlow Software. The PressureWire™ X guidewire is a hydrophilic-coated wire with pressure and temperature sensors that is capable of measuring physiologic indices including fractional flow reserve (FFR), resting full cycle ratio (RFR), coronary flow reserve (CFR), and the index of microcirculatory resistance (IMR). The guidewire wirelessly transmits pressure and temperature data via the Wi-Box to the CoroHub Receiver and CoroFlow Software, which is a software interface designed to display pressure measurements, thermodilution curves, and physiologic indices. This registry will enroll 500 subjects at up to 10 sites in the United States that use the Abbott Coroventis Coroflow Cardiovascular System.
The overall objective of this multi-center registry is to identify specific phenotypes of INOCA with both an anatomic evaluation (coronary angiography and intravascular imaging) and physiologic assessment with the Abbott Coroventis Coroflow Cardiovascular System, and to determine long-term outcomes. Specific goals include:
* Describe the prevalence of the following INOCA phenotypes: coronary microvascular dysfunction (CMD), vasospastic angina, mixed CMD/vasospastic angina, other disorders of coronary physiology, and non-cardiac chest pain;
* Characterize the burden of epicardial coronary artery atherosclerosis and myocardial bridging (MB) by angiography and intracoronary imaging (intravascular ultrasound or optical coherence tomography) in patients with INOCA;
* Characterize the natural history and outcomes of patients with INOCA and determine variables associated with major adverse cardiovascular events
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire
Patients presenting with symptomatic ischemic heart disease (including chronic stable angina or unstable angina) without evidence of myocardial infarction who require elective or urgent cardiac catheterization, and who meet all eligibility criteria will be enrolled.
Participants will undergo routine coronary angiography as well as comprehensive physiologic assessment with intracoronary acetylcholine provocation for diagnosis of vasospastic angina (VSA), coronary thermodilution to evaluate for coronary microvascular dysfunction (CMD), and intracoronary imaging with optical coherence tomography (OCT) or intravascular ultrasound (IVUS) to evaluate for the presence of atheroma, plaque burden, and myocardial bridging.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No obstructive coronary artery disease (CAD) as defined by operator visual assessment with (1) angiographically normal coronary arteries OR (2) non-obstructive CAD with angiographic stenosis \< 50%, or greater than or equal to 50 but \< 70% with FFR greater than or equal to 0.81 or RFR greater than or equal to 0.90
* Willing to comply with specified follow-up evaluations. The participant or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
Exclusion Criteria
* Any myocardial infarction at index presentation or within 90 days prior to enrollment, defined as any electrocardiogram diagnostic for myocardial infarction OR elevation in serum troponin greater than the upper limit of the site-defined reference range
* Known left ventricular ejection fraction \< 50% or cardiogenic shock requiring pressors or mechanical circulatory assistance (e.g., intra-aortic balloon pump, left ventricular assist device, other temporary cardiac support blood pump)
* Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation) or dialysis at the time of screening
* Prior percutaneous coronary intervention
* Planned percutaneous coronary intervention (PCI)
* Prior coronary artery bypass graft surgery
* Prior ST-elevation myocardial infarction
* History of hypertrophic cardiomyopathy
* History of infiltrative heart disease (e.g., cardiac amyloidosis)
* New York Heart Association Class IV congestive heart failure
* Severe mitral regurgitation
* Severe aortic stenosis
* Severe pulmonary hypertension (Mean pulmonary artery pressure greater than or equal to 35mmHg or echocardiographic right ventricular systolic pressure greater than or equal to 60mmHg)
* Known history of unrepaired or repaired congenital heart disease
* Past or pending heart transplant, or on the waiting list for organ transplant
* Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol, or is associated with a life expectancy of less than 1 year
* Current or planned participation in a study of an investigational therapy
* Angiographic stenosis in any major epicardial vessel ≥ 70% by visual estimate
* Angiographic stenosis in any major epicardial vessel greater than or equal to 50% and \< 70% by visual estimate with FFR less than or equal to 0.80 or RFR less than or equal to 0.89
18 Years
ALL
Yes
Sponsors
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Abbott
INDUSTRY
Yale University
OTHER
Responsible Party
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Principal Investigators
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Samit Shah, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University Medical School
Alexandra Lansky, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University Medical School
Locations
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UCLA Health
Los Angeles, California, United States
Stanford Hospital
Stanford, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
New York Presbyterian-Brooklyn Methodist Hospital
Brooklyn, New York, United States
NYU Langone Health
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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YSI-001
Identifier Type: -
Identifier Source: org_study_id