ACTIVE_NOT_RECRUITING

The DISCOVER INOCA Prospective Multi-center Registry

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

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-09-14

Study Completion:2032-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05288361

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Samit Shah, MD, PhD

PRINCIPAL_INVESTIGATOR

Yale University Medical School

Alexandra Lansky, MD

PRINCIPAL_INVESTIGATOR

Yale University Medical School

Study Locations (Sites)

UCLA Health

Los Angeles, California, 90095

United States

Stanford Hospital

Stanford, California, 94305

United States

Yale New Haven Hospital

New Haven, Connecticut, 06520

United States

Northeast Georgia Medical Center

Gainesville, Georgia, 30501

United States

New York Presbyterian-Brooklyn Methodist Hospital

Brooklyn, New York, 11215

United States

NYU Langone Health

New York, New York, 10010

United States

Columbia University Irving Medical Center

New York, New York, 10032

United States

The Christ Hospital

Cincinnati, Ohio, 45219

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Yale University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-14

Study Completion Date2032-12-31

Study Record Updates

Study Start Date2022-09-14

Study Completion Date2032-12-31

Terms related to this study

Additional Relevant MeSH Terms

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