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PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease

NCT05031520 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2025-04-29

No results posted yet for this study

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.

Conditions

  • Non-Obstructive Coronary Atherosclerosis

Interventions

PROCEDURE

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.

DRUG

Isovue

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

DRUG

Nitroglycerin

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

DRUG

Metoprolol

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

Sponsors & Collaborators

Principal Investigators

  • Nathaniel Smilowitz, MD · NYU Langone Health

Eligibility

Min Age
18 Years
Max Age
125 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2024-09-01
Completion
2024-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05031520 on ClinicalTrials.gov