Epicardial Fat in Coronary Artery Disease
Epicardial Fat as Brown Fat in Coronary Artery Disease
1 other identifier
observational
43
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 18, 2011
CompletedFirst Submitted
Initial submission to the registry
September 30, 2018
CompletedFirst Posted
Study publicly available on registry
October 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2019
CompletedApril 17, 2019
April 1, 2019
7.3 years
September 30, 2018
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EAT thermoregulatory genes
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?
24 hours
Secondary Outcomes (1)
Subcutaneous fat genes
24 hours
Study Arms (2)
Coronary Artery Disease (CAD)
Patients with clinically and angiographically established coronary artery disease (CAD) who require CABG, as part of the standard medical care.
controls
Control group will be formed by 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).
Interventions
CABG, as part of the standard medical care
cardiac surgery for aortic or mitral valve replacement as part of their standard medical care
Eligibility Criteria
The total number of patients participating in the research will be 60. The study group will be formed by 50 consecutive patients, male and female, age 50-75 years, Caucasian, Hispanic and African American, patients with clinically and angiographically established CAD who will undergo CABG, as part of their standard medical care. The control group will be formed by 10 subjects male and female age 50-75 years, 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.
You may qualify if:
- Subjects with clinically and angiographically established CAD
- Controls: subjects with have no history, clinical signs of CAD, and show normal coronary arteries on coronary angiography, who will undergo cardiac surgery for aortic or mitral valve replacement as part of their standard medical care
You may not qualify if:
- Patients with heart failure, kidney failure or liver failure, infective disease or cancer will be excluded from the study. Subjects taking glucocorticoids or estrogens or patients currently smoking will be excluded from the study. Patients with mental disorders will also not be included
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
Biospecimen
Adipose tissue will be collected during the cardiac surgery. Epicardial adipose tissue (EAT) biopsy samples (average 0.5-1.0 g) will be taken by cardiac surgeon after anesthesia, before heparin administration, near the proximal tract of the right coronary artery. Each tissue sample will be snap frozen in liquid nitrogen and stored at -80 °C until analysis in a freezer . The subcutaneous fat tissue (SAT) will be harvested at the site of the thoracic wound and preserved in the same manner.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
September 30, 2018
First Posted
October 2, 2018
Study Start
December 18, 2011
Primary Completion
April 15, 2019
Study Completion
April 15, 2019
Last Updated
April 17, 2019
Record last verified: 2019-04