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NCT03693261 · ClinicalTrials.gov registry record
Epicardial Fat in Coronary Artery Disease
A clinical trial, sponsored by University of Miami.
- Completed
- Registry status
- 43
- Enrollment target
NCT03693261: Completed study, sponsored by University of Miami.
NCT03693261 is a clinical trial that has completed, run by University of Miami. The registered enrollment target is 43 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03693261 has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- 43 participants
- Enrollment target
Study Summary
We hypothesize that human epicardial fat plays a thermogenic role to the myocardium. We hypothesize that epicardial fat may express genes of brown fat and thyroid function that are down-regulated by the presence of coronary artery disease. Because the postulated metabolic role of the epicardial fat, we also hypothesize that the gene expression of these regulatory thermogenic factors is higher in epicardial than subcutaneous fat This will be a cross-sectional study conducted over a one-year period in patients with or without coronary artery disease who require elective cardiac surgery regardless their participation in the study. Study group will be formed by 50 patients with clinically and angiographically established CAD who will undergo coronary artery bypass graft, as part of their standard medical care. Control group will be formed by 10 subjects, randomly selected, who will undergo cardiac surgery for aortic or mitral valve replacement as part of their standard medical care (these patients have no history, clinical signs of CAD, and show normal coronary arteries on coronary angiography). This will be a cross-sectional study conducted over a one-year period in patients with or without coronary artery disease who require elective cardiac surgery regardless their participation in the study. Adipose tissue will be collected during the cardiac surgery.
Primary Outcome
Does human epicardial fat express makers of brown adipose tissue, such UCP-1 and brown adipocyte differentiation transcription factors in subjects with and without coronary artery disease? Does human epicardial fat express type 2 and type 3 deiodinase, thyroid hormones and β-3 adrenergic receptors in subjects with and without coronary artery disease? Is the thermoregulatory function of the human epicardial fat correlated to the presence and severity of coronary artery disease?
Interventions
- PROCEDURE Coronary artery bypass grafting (CABG)
- PROCEDURE Valve replacement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2011-12-18 |
| Est. Completion | 2019-04-15 |
What the finished NCT03693261 record still lists
NCT03693261 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 43 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Coronary artery bypass grafting (CABG) is the first listed.
NCT03693261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03693261 about?
NCT03693261 is a clinical study titled "Epicardial Fat in Coronary Artery Disease". We hypothesize that human epicardial fat plays a thermogenic role to the myocardium. We hypothesize that epicardial fat may express genes of brown fat and thyroid function that are down-regulated by the presence of coronary artery disease. Because the postulated metabolic role of the epicardial fat,...
What is the current status of trial NCT03693261?
This trial is currently completed. The enrollment target is 43 participants. The study started on 2011-12-18. Estimated completion is 2019-04-15.
What interventions are being tested in trial NCT03693261?
The interventions under investigation include: Coronary artery bypass grafting (CABG) (PROCEDURE), Valve replacement (PROCEDURE).
Who is sponsoring clinical trial NCT03693261?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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