The DISCOVER INOCA Prospective Multi-center Registry

NCT05288361 | Active Not Recruiting

• 1 other identifier: YSI-001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• The proportion of subjects with each physiologic phenotypes diagnosed with the Coroflow Cardiovascular System will be reported within 24-48 hours of the procedure.

  The following phenotypes will be captured: Coronary microvascular dysfunction (CMD)- Criteria for a diagnosis of CMD include an abnormal Index of Microcirculatory Resistance (IMR) ≥ 25 and/or impaired Coronary Flow Reserve (CFR) ≤ 2.0; Vasospastic angina (VSA): Includes coronary vasospasm, microvascular spasm, and endothelial dysfunction. Criteria for coronary vasospasm include ≥ 90% narrowing of the epicardial vessel during acetylcholine testing and either or both angina and transient ischemic EKG changes. Microvascular spasm includes angina and/or ischemic EKG changes in the absence of spasm of the epicardial vessel during acetycholine infusion; Endothelial dysfunction as defined as angiographic diameter change less than or equal to 0% and but not greater than -89% in response to acetylcholine infusion; Mixed CMD/VSA; Any other disorders of coronary physiology.

  up to 48 hours after the procedure

• The proportion of subjects that experience Major Adverse Cardiovascular Events (MACE)

  The proportion of subjects that experience Major Adverse Cardiovascular Events (MACE) as reported by the clinical study sites and adjudicated by the Clinical Events Committee (CEC). Reports may come from the clinical site or self report. MACE defined as a composite of cardiovascular death, myocardial infarction, hospitalization for cardiovascular causes or coronary revascularization.

  Up to 5 years

• The proportion of subjects that exhibit mild, moderate or severe coronary artery stenosis

  The proportion of subjects that exhibit mild, moderate or severe coronary artery stenosis as measured by Optical Coherence Tomography (OCT), Intravascular Ultrasound (IVUS) or Quantitative Coronary Angiography (QCA). Mild stenosis is defined as less than or equal to 30%, Moderate stenosis is defined as 31%-69%, and severe stenosis is greater than or equal to 70%. The measurements will take place during the procedure and the analysis will be completed by a central core lab.

  At the time of the procedure

• Lesion length during the procedure

  Lesion length during the procedure will be determined for each subject by the use of OCT, IVUS or QCA and the analysis will be completed by a central core lab. Lesion length will be defined by either less than 15mm or equal to or greater than 15mm.

  At the time of the procedure

Secondary Outcomes (17)

• The proportion of subjects that experience Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at any time during the study.

  Up to 5 Years

• The proportion of subjects that die at any time in the study

  Up to 5 years

• The proportion of subjects that experience a Myocardial Infarction (MI) at any time during the study.

  Up to 5 Years

• The proportion of subjects that experience a stroke at any time during the study.

  Up to 5 years

• The proportion of subjects that require revascularization of their coronary arteries at any time during the study.

  Up to 5 years

Interventions

Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire DIAGNOSTIC_TEST

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.

Also known as: Acetylcholine Provocation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults referred to the catheterization laboratory for evaluation of suspected ischemic heart disease, and who are deemed to have non-obstructive coronary artery disease based on coronary angiography or non-ischemic fractional flow reserve (FFR) or resting free cycle ratio (RFR).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Abbott: collaborator

Study Sites (9)

UCLA Health

Los Angeles, California, 90095, United States

Location

Stanford Hospital

Stanford, California, 94305, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

New York Presbyterian-Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

NYU Langone Health

New York, New York, 10010, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Ischemia; Coronary Vasospasm; Microvascular Angina

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris

Study Officials

• Samit Shah, MD, PhD

  Yale University Medical School

  PRINCIPAL INVESTIGATOR

• Alexandra Lansky, MD

  Yale University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 21, 2022
• Study Start: September 14, 2022
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)