Skip to main content
OpenTrials
Completed

NCT Number: NCT02965625

Characterization of Epicardial and Pericardial Adipose Tissue in Coronary Artery Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Physical Activity Research

Copenhagen, 2200, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Characterization of cardiac adipose tissue

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Cardiac adipose tissue volume

    Time frame: 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.

  4. Functional characterization of cardiac adipose biopsy cell culture

    Time frame: 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. Gene expression will be measured.

  5. Functional characterization of cardiac adipose biopsy cell culture

    Time frame: 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.

  6. Cardiac muscle biopsies

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2016
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.