NCT05031520

PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 125 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-12
• Primary completion: 2024-09-01
• Completion: 2024-12-31
• First posted: 2021-09-02
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States