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NCT05031520 · ClinicalTrials.gov registry record
PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease
A clinical trial, sponsored by NYU Langone Health.
- Terminated
- Registry status
- 32
- Enrollment target
NCT05031520: Clinical Trial study, sponsored by NYU Langone Health.
NCT05031520 is a clinical trial that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05031520 was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- 32 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- DRUG Metoprolol
- DRUG Nitroglycerin
- DRUG Isovue
- PROCEDURE Coronary computed tomography angiography (CCTA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-07-12 |
| Est. Completion | 2024-12-31 |
Why NCT05031520 stopped before completion
NCT05031520 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Metoprolol is the first listed.
NCT05031520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05031520 about?
NCT05031520 is a clinical study titled "PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease". 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 preferentiall...
What is the current status of trial NCT05031520?
This trial is currently terminated. The enrollment target is 32 participants. The study started on 2021-07-12. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT05031520?
The interventions under investigation include: Metoprolol (DRUG), Nitroglycerin (DRUG), Isovue (DRUG), Coronary computed tomography angiography (CCTA) (PROCEDURE).
Who is sponsoring clinical trial NCT05031520?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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