Characterization of Epicardial and Pericardial Adipose Tissue in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

Characterization of Epicardial and Pericardial Adipose Tissue in Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965625
• Other study ID #: H-16031413
• Status: Completed
• Start date: October 2016
• Est. completion date: June 2018

Study information

• Verified date: November 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Denmark	Centre for Physical Activity Research	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen University Hospital, Denmark, The Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Characterization of cardiac adipose tissue gene expression in coronary artery bypass graft (CABG) and valve replacement surgery patients	Gene expression will be measured and compared within cardiac adipose tissue biopsies from patients undergoing CABG or valve replacement surgery.	Time of collection during surgery is approximately 3 hours
Secondary	Characterization of cardiac adipose tissue protein expression in coronary artery bypass graft (CABG) and valve replacement surgery patients	Protein expression will be measured and compared within cardiac adipose tissue biopsies from patients undergoing CABG or valve replacement surgery.	Time of collection during surgery is approximately 3 hours
Secondary	Cardiac adipose tissue volume	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.	Prior to surgery
Secondary	Functional characterization of cardiac adipose biopsy cell culture	Primary cell culture will be derived from the cardiac adipose biopsies to perform functional assays in vitro. Gene expression will be measured.	Time of collection during surgery is approximately 3 hours
Secondary	Functional characterization of cardiac adipose biopsy cell culture	Primary cell culture will be derived from the cardiac adipose biopsies to perform functional assays in vitro. Protein expression will be measured.	Time of collection during surgery is approximately 3 hours
Secondary	Cardiac muscle biopsies	Gene expression in cardiac muscle biopsies and progenitor cells will be compared to that of the adipose biopsies.	Time of collection during surgery is approximately 3 hours