PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease
- Conditions
- Non-Obstructive Coronary Atherosclerosis
- Interventions
- Procedure: Coronary computed tomography angiography (CCTA)
- Registration Number
- NCT05031520
- Lead Sponsor
- NYU Langone Health
- Brief Summary
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.
- Detailed Description
The PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease (POINT-NOCAD) study is a single-center diagnostic, observational study enrolling men and women with MINOCA or INOCA who are planned to undergo (or underwent) clinically indicated coronary angiography. The research plan is to evaluate coronary inflammation, as measured by the perivascular coronary fat attenuation index from non-invasive coronary computed tomography angiography (CCTA), in patients with MINOCA and INOCA.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 100
- Adult age ≥18 years referred for clinically indicated coronary angiography
- Stable ischemic heart disease OR acute myocardial infarction as the indication for coronary angiography
Clinical Exclusion criteria:
- Estimated glomerular filtration rate < 45 mL/min
- History of allergic reaction to iodinated contrast media
- Pregnancy
Angiographic / Post-Cath Exclusion criteria:
- Obstructive CAD (≥50% luminal obstruction in ≥1 major epicardial coronary arteries by invasive coronary angiography)
- Allergic reaction to iodinated contrast media
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intervention group Coronary computed tomography angiography (CCTA) Participants will be identified by review of the cardiac catheterization laboratory schedule each day by the principal investigator, a co-investigator, or a research coordinator. Participants with no obstructive CAD and completed microvascular testing will undergo a research CCTA. Intervention group Isovue Participants will be identified by review of the cardiac catheterization laboratory schedule each day by the principal investigator, a co-investigator, or a research coordinator. Participants with no obstructive CAD and completed microvascular testing will undergo a research CCTA. Intervention group Nitroglycerin Participants will be identified by review of the cardiac catheterization laboratory schedule each day by the principal investigator, a co-investigator, or a research coordinator. Participants with no obstructive CAD and completed microvascular testing will undergo a research CCTA. Intervention group Metoprolol Participants will be identified by review of the cardiac catheterization laboratory schedule each day by the principal investigator, a co-investigator, or a research coordinator. Participants with no obstructive CAD and completed microvascular testing will undergo a research CCTA.
- Primary Outcome Measures
Name Time Method Perivascular coronary fat attenuation will be significantly greater in MINOCA patients compared with INOCA patients Visit 1, Day 0 Images obtained from the CCTA will be used to calculate perivascular FAI, measured around the proximal left anterior descending artery and in the right coronary artery, in the proximal 10 to 50 mm of the vessel. For each coronary vessel, will define the weighted mean attenuation of all adipose tissue-containing voxels (-190 to -30 Hounsfield units \[HU\]) located within a radial distance from the outer vessel wall equal to the diameter of the respective vessel.
Perivascular coronary fat attenuation will be greater in INOCA patients with versus without coronary microvascular disease Visit 1, Day 0 Images obtained from the CCTA will be used to calculate perivascular FAI, measured around the proximal left anterior descending artery and in the right coronary artery, in the proximal 10 to 50 mm of the vessel. For each coronary vessel, will define the weighted mean attenuation of all adipose tissue-containing voxels (-190 to -30 Hounsfield units \[HU\]) located within a radial distance from the outer vessel wall equal to the diameter of the respective vessel.
Perivascular coronary fat attenuation in patients with MINOCA will be greatest in the culprit coronary vessels with evidence of acute plaque disruption. Visit 1, Day 0 Images obtained from the CCTA will be used to calculate perivascular FAI, measured around the proximal left anterior descending artery and in the right coronary artery, in the proximal 10 to 50 mm of the vessel. For each coronary vessel, will define the weighted mean attenuation of all adipose tissue-containing voxels (-190 to -30 Hounsfield units \[HU\]) located within a radial distance from the outer vessel wall equal to the diameter of the respective vessel.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States