The DISCOVER INOCA Prospective Multi-center Registry

About

Brief Summary

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.

Study Type

Observational

Phase

Phase 4

Eligibility

Gender

All

Healthy Volunteers

Yes

Minimum Age

18 Years

Maximum Age

N/A

Inclusion 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)

Exclusion Criteria:

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