PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease

NCT ID: NCT05031520

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2024-12-31

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.

Conditions

Non-Obstructive Coronary Atherosclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Coronary computed tomography angiography (CCTA)

Intervention Type: PROCEDURE

Participants will undergo CCTA. CCTA performed in this study will be technically identical to CCTA that is commonly performed in clinical practice, for which safety profiles are well defined. Guidelines implemented by the National Institutes of Health Radiation Exposure Committee will be followed. Major risks of CCTA include exposure to ionizing radiation, the requirement for intravenous catheter placement and contrast media administration, and side effects of beta-blockers and nitrates that may be used for vasodilation and heart rate control to optimize CCTA image quality.

Isovue

Intervention Type: DRUG

CCTA requires intravenous catheter placement and the administration of iodinated contrast media (Isovue).

Nitroglycerin

Intervention Type: DRUG

Medication to promote coronary vasodilation during the CCTA may be administered immediately prior to CCTA to optimize image quality

Metoprolol

Intervention Type: DRUG

Medication to promote heart rate reduction during the CCTA may be administered immediately prior to CCTA to optimize image quality

Interventions

Coronary computed tomography angiography (CCTA)

Participants will undergo CCTA. CCTA performed in this study will be technically identical to CCTA that is commonly performed in clinical practice, for which safety profiles are well defined. Guidelines implemented by the National Institutes of Health Radiation Exposure Committee will be followed. Major risks of CCTA include exposure to ionizing radiation, the requirement for intravenous catheter placement and contrast media administration, and side effects of beta-blockers and nitrates that may be used for vasodilation and heart rate control to optimize CCTA image quality.

Intervention Type: PROCEDURE

Isovue

CCTA requires intravenous catheter placement and the administration of iodinated contrast media (Isovue).

Intervention Type: DRUG

Nitroglycerin

Medication to promote coronary vasodilation during the CCTA may be administered immediately prior to CCTA to optimize image quality

Intervention Type: DRUG

Metoprolol

Medication to promote heart rate reduction during the CCTA may be administered immediately prior to CCTA to optimize image quality

Intervention Type: DRUG

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 125 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathaniel Smilowitz, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

21-00764

Identifier Type: -

Identifier Source: org_study_id