PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease
Among patients with ischemic heart disease who are referred for coronary angiography, a substantial proportion have non-obstructive coronary artery disease (CAD). Myocardial infarction (MI) with non-obstructive coronary artery disease (MINOCA) accounts for 5-20% of patients with MI and preferentially affects women. MINOCA pathogenesis is varied and may include atherosclerotic plaque rupture, plaque erosion with thrombosis, vasospasm, embolization, dissection or a combination of mechanisms. Other patients may have clinically unrecognized myocarditis, or takotsubo syndrome masquerading as MI. Among patients referred for coronary angiography for the evaluation of stable ischemic heart disease, non-obstructive CAD is present in up to \~30% of men and \~60% of women. Stable ischemia with non-obstructive coronary arteries (INOCA) may be due to coronary microvascular dysfunction in up to 40% of these patients. Our understanding of mechanisms of MINOCA and INOCA remain incomplete. Coronary inflammation has been hypothesized as a potential mechanism contributing to coronary spasm in MINOCA and microvascular disease in INOCA.
Conditions:
🦠 Non-Obstructive Coronary Atherosclerosis
🗓️ Study Start (Actual) 12 July 2021
🗓️ Primary Completion (Estimated) July 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 100
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Adult age ≥18 years referred for clinically indicated coronary angiography
    • * Stable ischemic heart disease OR acute myocardial infarction as the indication for coronary angiography

    Exclusion Criteria:

    • * Estimated glomerular filtration rate \< 45 mL/min
    • * History of allergic reaction to iodinated contrast media
    • * Pregnancy
    • * Obstructive CAD (≥50% luminal obstruction in ≥1 major epicardial coronary arteries by invasive coronary angiography)
    • * Allergic reaction to iodinated contrast media
Ages Eligible for Study: 18 Years to 125 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 24 August 2021
  • First Submitted that Met QC Criteria 31 August 2021
  • First Posted 2 September 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 May 2024
  • Last Update Posted 2 May 2024
  • Last Verified May 2024