Characterization of Epicardial and Pericardial Adipose Tissue in Coronary Artery Disease

NCT02965625 | Completed

• 1 other identifier: H-16031413
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Human epicardial fat is the true visceral fat depot of the heart, and its regional distribution and physiology is of growing scientific and clinical interest. This study aims to characterize the expression profile and function of the epicardial and pericardial adipose tissue compartments of the heart (EAT and PAT). EAT and PAT adipose biopsies will be obtained from patients undergoing coronary artery bypass graft surgery (CABG) or valve replacement surgery.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Characterization of cardiac adipose tissue

  Cardiac adipose tissue biopsies will be compared and characterized as brown, beige or white adipose according to gene expression of adipocyte markers

  Time of collection during surgery is approximately 3 hours

Secondary Outcomes (6)

• Characterization of cardiac adipose tissue gene expression in coronary artery bypass graft (CABG) and valve replacement surgery patients

  Time of collection during surgery is approximately 3 hours

• Characterization of cardiac adipose tissue protein expression in coronary artery bypass graft (CABG) and valve replacement surgery patients

  Time of collection during surgery is approximately 3 hours

• Cardiac adipose tissue volume

  Prior to surgery

• Functional characterization of cardiac adipose biopsy cell culture

  Time of collection during surgery is approximately 3 hours

• Functional characterization of cardiac adipose biopsy cell culture

  Time of collection during surgery is approximately 3 hours

Study Arms (1)

open elective cardiac surgery patients

Including coronary artery bypass graft and valve replacement surgery patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing open elective cardiac surgery, specifically coronary artery bypass graft and valve replacement surgery.

You may qualify if:

• Age \<80 years
• Patients undergoing elective heart surgery either for coronary bypass grafting or for other purposes

You may not qualify if:

• Inability of the patient to provide informed consent
• Severe kidney failure, GFR\<30
• Previous cardio-thoracic surgery

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen University Hospital, Denmark: collaborator
• University of Copenhagen: collaborator
• The Novo Nordisk Foundation Center for Basic Metabolic Research: collaborator

Study Sites (1)

Centre for Physical Activity Research

Copenhagen, 2200, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Whole blood Serum Cardiac adipose tissue Cardiac adipose tissue cell culture

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Regitse H Christensen, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Sarah E Heywood, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: November 17, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)