Clinical trial NCT02965625: Characterization of Epicardial and Pericardial Adipose Tissue in Coronary Artery Disease
Official title: Characterization of Epicardial and Pericardial Adipose Tissue in Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Denmark
name: University of Copenhagen
name: The Novo Nordisk Foundation Center for Basic Metabolic Research
First posted: 2016-11-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing open elective cardiac surgery, specifically coronary artery bypass graft and valve replacement surgery.

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

Eligibility criteria: 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

Primary outcomes:
measure: Characterization of cardiac adipose tissue
timeFrame: Time of collection during surgery is approximately 3 hours
Secondary outcomes:
measure: Characterization of cardiac adipose tissue gene expression in coronary artery bypass graft (CABG) and valve replacement surgery patients
timeFrame: Time of collection during surgery is approximately 3 hours
measure: Characterization of cardiac adipose tissue protein expression in coronary artery bypass graft (CABG) and valve replacement surgery patients
timeFrame: Time of collection during surgery is approximately 3 hours
measure: Cardiac adipose tissue volume
timeFrame: Prior to surgery
measure: Functional characterization of cardiac adipose biopsy cell culture
timeFrame: Time of collection during surgery is approximately 3 hours
measure: Functional characterization of cardiac adipose biopsy cell culture
timeFrame: Time of collection during surgery is approximately 3 hours
measure: Cardiac muscle biopsies
timeFrame: Time of collection during surgery is approximately 3 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Centre for Physical Activity Research
Study officials:
affiliation: Rigshospitalet, Denmark
name: Regitse H Christensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Sarah E Heywood, PhD
role: PRINCIPAL_INVESTIGATOR
References: