Registry for patients with ischemia and no obstructive coronary artery disease

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

This study is trying to learn more about patients who have chest pain but no blocked arteries by looking at their heart function and blood flow to see how they do over time.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yale University (other)
• Locations: 9 sites (Los Angeles, California and 8 other locations)
• Trial ID: NCT05288361 on ClinicalTrials.gov

What this trial studies

This multi-center registry aims to identify specific phenotypes of ischemia and no obstructive coronary artery disease (INOCA) through anatomic evaluations using coronary angiography and intravascular imaging, alongside physiologic assessments using the Abbott Coroventis Coroflow Cardiovascular System. The registry will enroll 500 stable patients across up to 10 sites in the United States. Participants will undergo evaluations that include measurements of fractional flow reserve, resting full cycle ratio, coronary flow reserve, and the index of microcirculatory resistance. The goal is to determine long-term outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are patients suspected of having ischemic heart disease who are referred for invasive coronary angiography and have no obstructive coronary artery disease.

Not a fit: Patients with recent myocardial infarction or those who are pregnant or nursing may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could enhance understanding and management of patients with ischemia and no obstructive coronary artery disease, leading to improved treatment strategies.

How similar studies have performed: Other studies have shown promise in similar approaches, but this registry focuses specifically on INOCA, making it a novel initiative.

Eligibility criteria

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

Where this trial is running

Los Angeles, California and 8 other locations

• UCLA Health — Los Angeles, California, United States (RECRUITING)
• Stanford Hospital — Stanford, California, United States (RECRUITING)
• Yale New Haven Hospital — New Haven, Connecticut, United States (RECRUITING)
• Northeast Georgia Medical Center — Gainesville, Georgia, United States (RECRUITING)
• New York Presbyterian-Brooklyn Methodist Hospital — Brooklyn, New York, United States (RECRUITING)
• NYU Langone Health — New York, New York, United States (RECRUITING)
• Columbia University Irving Medical Center — New York, New York, United States (RECRUITING)
• The Christ Hospital — Cincinnati, Ohio, United States (RECRUITING)
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Samit Shah, MD, PhD — Yale University Medical School
• Study coordinator: Cody Pietras

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