PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease

Non-Obstructive Coronary Atherosclerosis Clinical Trial

— POINT-NOCAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05031520
• Other study ID #: 21-00764
• Status: Recruiting
• Start date: July 12, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Nathaniel Smilowitz, MD
• Phone: 212-263-5656
• Email: Nathaniel.Smilowitz[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 125 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Inflammation
• Myocardial Ischemia
• Non-Obstructive Coronary Atherosclerosis

Intervention

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).
• Nitroglycerin
Medication to promote coronary vasodilation during the CCTA may be administered immediately prior to CCTA to optimize image quality
• Metoprolol
Medication to promote heart rate reduction during the CCTA may be administered immediately prior to CCTA to optimize image quality

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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