PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease

NCT05031520 | Terminated DMC

• 1 other identifier: 21-00764
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Obstructive Coronary Atherosclerosis

Outcome Measures

Primary Outcomes (3)

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

  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.

  Visit 1, Day 0

• Perivascular coronary fat attenuation will be greater in INOCA patients with versus without coronary microvascular disease

  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.

  Visit 1, Day 0

• Perivascular coronary fat attenuation in patients with MINOCA will be greatest in the culprit coronary vessels with evidence of acute plaque disruption.

  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.

  Visit 1, Day 0

Study Arms (1)

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.

Procedure: Coronary computed tomography angiography (CCTA); Drug: Isovue; Drug: Nitroglycerin; Drug: Metoprolol

Interventions

Coronary computed tomography angiography (CCTA) 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.

Intervention group

Isovue DRUG

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

Intervention group

Nitroglycerin DRUG

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

Intervention group

Metoprolol DRUG

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 125 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults presenting to the NYU Langone Health Tisch/Kimmel Cardiac Catheterization Laboratory or the Bellevue Cardiac Catheterization laboratory will be screened and approached for consent if the patient's treating provider is amenable to their participation in the research study and if the patient is eligible for enrollment based on the eligibility criteria prior to clinically indicated cardiac catheterization.

You may qualify if:

• Adult age ≥18 years referred for clinically indicated coronary angiography
• Stable ischemic heart disease OR acute myocardial infarction as the indication for coronary angiography

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Iopamidol; Nitroglycerin; Metoprolol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Nitro Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines

Study Officials

• Nathaniel Smilowitz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 2, 2021
• Study Start: July 12, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 31, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Nathaniel.Smilowitz@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)