Characterization of Epicardial and Pericardial Adipose Tissue in Coronary Artery Disease

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02965625
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

The epicardial adipose tissue (EAT) stretches from the myocardium to the visceral layer of the pericardium. Adipose located on the outside of the visceral pericardium to the external site of the pericardium is called the pericardial adipose tissue (PAT), and is of a separate origin than EAT. Therefore, this study aims to investigate the global expression profile of the EAT and PAT compartments, in addition to characterizing the function, structure, metabolic and inflammatory profile. Furthermore, this study will determine whether CABG and valve replacement patients display different EAT and PAT characteristics

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-17
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-25
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

• Inability of the patient to provide informed consent
• Severe kidney failure, GFR<30
• Previous cardio-thoracic surgery
• There are no other specific exclusion criteria, as long as the patient is considered eligible for surgery by the clinicians

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of cardiac adipose tissue	Time of collection during surgery is approximately 3 hours	Cardiac adipose tissue biopsies will be compared and characterized as brown, beige or white adipose according to gene expression of adipocyte markers

Secondary Outcome Measures

Name	Time	Method
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	Protein expression will be measured and compared within cardiac adipose tissue biopsies from patients undergoing CABG or valve replacement surgery.
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	Gene expression will be measured and compared within cardiac adipose tissue biopsies from patients undergoing CABG or valve replacement surgery.
Functional characterization of cardiac adipose biopsy cell culture	Time of collection during surgery is approximately 3 hours	Primary cell culture will be derived from the cardiac adipose biopsies to perform functional assays in vitro. Protein expression will be measured.
Cardiac adipose tissue volume	Prior to surgery	Cardiac fat volume will be measured by cardiac MRI scan prior to undergoing CABG or valve replacement surgery to assess whether cardiac fat volume correlates with the cardiac adipose profile.
Cardiac muscle biopsies	Time of collection during surgery is approximately 3 hours	Gene expression in cardiac muscle biopsies and progenitor cells will be compared to that of the adipose biopsies.

Trial Locations

Locations (1)

Centre for Physical Activity Research; 🇩🇰 Copenhagen, Denmark