Clinical trial NCT05031520: PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease
Official title: A Single Center Study of Perivascular Coronary Inflammation in Patients With Myocardial Ischemia or Infarction With Non-Obstructive Coronary Arteries
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-Obstructive Coronary Atherosclerosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 125
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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:

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

Primary outcomes:
measure: Perivascular coronary fat attenuation will be significantly greater in MINOCA patients compared with INOCA patients
timeFrame: Visit 1, Day 0
measure: Perivascular coronary fat attenuation will be greater in INOCA patients with versus without coronary microvascular disease
timeFrame: Visit 1, Day 0
measure: Perivascular coronary fat attenuation in patients with MINOCA will be greatest in the culprit coronary vessels with evidence of acute plaque disruption.
timeFrame: Visit 1, Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nathaniel Smilowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: