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Clinical Trials/NCT05031520
NCT05031520
Terminated
Not Applicable

A Single Center Study of Perivascular Coronary Inflammation in Patients With Myocardial Ischemia or Infarction With Non-Obstructive Coronary Arteries

NYU Langone Health1 site in 1 country100 target enrollmentJuly 12, 2021

Overview

Phase
Not Applicable
Intervention
Coronary computed tomography angiography (CCTA)
Conditions
Non-Obstructive Coronary Atherosclerosis
Sponsor
NYU Langone Health
Enrollment
100
Locations
1
Primary Endpoint
Perivascular coronary fat attenuation will be significantly greater in MINOCA patients compared with INOCA patients
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 12, 2021
End Date
December 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • 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

Arms & Interventions

Intervention group

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: Coronary computed tomography angiography (CCTA)

Intervention group

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: Isovue

Intervention group

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: Nitroglycerin

Intervention group

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: Metoprolol

Outcomes

Primary Outcomes

Perivascular coronary fat attenuation will be significantly greater in MINOCA patients compared with INOCA patients

Time Frame: 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

Time Frame: 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.

Time Frame: 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.

Study Sites (1)

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