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Phase Pilot

The DISCOVER INOCA Prospective Multi-center Registry - Determining the Cause of Coronary Vasomotor Disorders in Patients with Ischemia and No Obstructive Coronary Artery Disease

  • Study HIC#:2000032344
  • Last Updated:12/22/2022

The DISCOVER INOCA registry is a study to help us understand the causes of chest pain, shortness of breath, or other symptoms of heart disease in people who don't have cholesterol blockages in their blood vessels. This disease, called ischemia and no obstructive coronary artery disease (INOCA), can give patients symptoms that look and feel just like a heart attack. Participants may be eligible if their heart doctor believes that they need a procedure called a "catheterization" or "angiogram" to look directly at the blood vessels. The study involves questionnaires to help us better understand our patients, and 5-years of phone follow-up. 

This is a patient experience story describing our work: http://c-hit.org/2022/08/29/yale-led-study-seeks-to-transform-heart-disease-diagnoses-in-women/

  • Age18 years and older
  • GenderBoth
  • Start Date09/07/2022
  • End Date03/31/2027

Trial Purpose and Description

The DISCOVER INOCA registry is a study to help us understand the causes of chest pain, shortness of breath, or other symptoms of heart disease in people who don't have cholesterol blockages in their blood vessels. This disease, called ischemia and no obstructive coronary artery disease (INOCA), can give patients symptoms that look and feel just like a heart attack. Participants may be eligible if their heart doctor believes that they need a procedure called a "catheterization" or "angiogram" to look directly at the blood vessels. The study involves questionnaires to help us better understand our patients, and 5-years of phone follow-up. 

This is a patient experience story describing our work: http://c-hit.org/2022/08/29/yale-led-study-seeks-to-transform-heart-disease-diagnoses-in-women/

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

For more information about this study, contact:

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