Coronary Artery DiseaseNCT02965625
Characterization of Epicardial and Pericardial Adipose Tissue in Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing open elective cardiac surgery, specifically coronary artery bypass graft and valve replacement surgery.
Who may be able to join
- Age <80 years
- Patients undergoing elective heart surgery either for coronary bypass grafting or for other purposes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| open elective cardiac surgery patients | Including coronary artery bypass graft and valve replacement surgery patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Gene expression will be measured and compared within cardiac adipose tissue biopsies from patients undergoing CABG or valve replacement surgery.
Measured: 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
Protein expression will be measured and compared within cardiac adipose tissue biopsies from patients undergoing CABG or valve replacement surgery.
Measured: Time of collection during surgery is approximately 3 hours
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.
Measured: Prior to surgery
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.
Measured: Time of collection during surgery is approximately 3 hours
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.
Measured: Time of collection during surgery is approximately 3 hours
Cardiac muscle biopsies
Gene expression in cardiac muscle biopsies and progenitor cells will be compared to that of the adipose biopsies.
Measured: Time of collection during surgery is approximately 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark, University of Copenhagen, The Novo Nordisk Foundation Center for Basic Metabolic Research
- Responsible party
- Principal investigator, Regitse Christensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Regitse H Christensen, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletSarah E Heywood, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965625
- Sponsor's protocol ID
- H-16031413
- Status last verified
- Nov 2020
- First submitted
- 5 Oct 2016
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Epicardial and Pericardial Adipose Tissue in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02965625
- Acronym / sponsor ID
- H-16031413
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark, University of Copenhagen, The Novo Nordisk Foundation Center for Basic Metabolic Research
- Study start
- Oct 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open elective cardiac surgery patients | – | –Including coronary artery bypass graft and valve replacement surgery patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing open elective cardiac surgery, specifically coronary artery bypass graft and valve replacement surgery.
Key inclusion criteria (2 listed)
- Age <80 years
- Patients undergoing elective heart surgery either for coronary bypass grafting or for other purposes
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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
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
Cardiac adipose tissue volume
Time frame: Prior to surgery
Functional characterization of cardiac adipose biopsy cell culture
Time frame: Time of collection during surgery is approximately 3 hours
Functional characterization of cardiac adipose biopsy cell culture
Time frame: Time of collection during surgery is approximately 3 hours
Cardiac muscle biopsies
Time frame: Time of collection during surgery is approximately 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regitse H Christensen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Sarah E Heywood, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of cardiac adipose tissue (time frame: Time of collection during surgery is approximately 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.