The DISCOVER INOCA Prospective Multi-center Registry

Description

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.

Conditions

Ischemia and No Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction, Coronary Vasospasm, Endothelial Dysfunction, Microvascular Angina, Chest Pain With Normal Coronary Angiography

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Study Overview

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Study Details

Study overview

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.

Determining the Cause of Coronary Vasomotor Disorders in Patients With Ischemia and No Obstructive Coronary Artery Disease

The DISCOVER INOCA Prospective Multi-center Registry

Condition
Ischemia and No Obstructive Coronary Artery Disease
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford Hospital, Stanford, California, United States, 94305

New Haven

Yale University, New Haven, Connecticut, United States, 06520

Gainesville

Northeast Georgia Medical Center, Gainesville, Georgia, United States, 30501

Brooklyn

New York Presbyterian-Brooklyn Methodist Hospital, Brooklyn, New York, United States, 11215

New York

NYU Langone Health, New York, New York, United States, 10010

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Cincinnati

The Christ Hospital, Cincinnati, Ohio, United States, 45219

Philadelphia

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Suspected ischemic heart disease and is referred to undergo clinically indicated invasive coronary angiography
  • * 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)
  • * Pregnant or nursing
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Yale University,

Samit Shah, MD, PhD, PRINCIPAL_INVESTIGATOR, Yale University Medical School

Alexandra Lansky, MD, PRINCIPAL_INVESTIGATOR, Yale University Medical School

Study Record Dates

2029-07-31