Coronary Artery DiseaseNCT00279227
Role of Epicardial Adipose Tissue in Coronary Artery Disease
An observational study of Coronary Artery Disease and Obesity, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
We sight to evaluate whether patients with coronary artery disease (CAD) have more epicardial fat than patients without CAD, which would suggest that epicardial fat may be more than an "innocent bystander" and be actively involved in the disease process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Obesity
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2006to Dec 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients elegible for elective cardiac surgery are elegible
- Ability to provide written informed consent in accordance with GCP guidelines and local legislations.
- > 18 years of age
Who cannot join
- Control patients will not have clinical signs of CAD and will show normal coronary arteries on angiography.
- Any medical, social or geographic condition, which, in the opinion of the investigator would not allow safe or reliable completion of the protocol.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences - Cardiovascular Obesity Research and Management Center
Hamilton, Ontario, L8L 2X2
Gianluca Iacobellis, MD PhD
Arya M Sharma, MD FRCPC
About this study
We sight to evaluate whether patients with coronary artery disease (CAD) have more epicardial fat than patients without CAD, which would suggest that epicardial fat may be more than an "innocent bystander" and be actively involved in the disease process. Its role as a modulator of vascular response and myocardial function could potentially lead to new areas of cardiac research. We also sight to evaluate whether epicardial fat from patients with CAD releases more adipokines than subcutaneous fat from these patients which could prompt studies into the differential regulation of adipokine secretion in this tissue. Thus for e.g., the use of thiazolidinediones (glitazones), statins, ARBs or other compounds that can specifically modulate adipokine secretion could be explored to determine their benefit in ameliorating the effects attributable to increased epicardial fat.
- Conditions
- Coronary Artery Disease, Obesity
- Keywords
- coronary artery disease, epicardial adipose tissue, epicardial fat, obesity
- Medical subject headings
- Coronary Artery Disease, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startJan 2006
- Study completionDec 2006
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.
- 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
- Defined population
- Time perspective
- Other
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Investigators
- Arya M Sharma, MD, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279227
- Sponsor's protocol ID
- EPICARD Study
- Status last verified
- Jan 2006
- First submitted
- 17 Jan 2006
- Last updated
- 15 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Epicardial Adipose Tissue in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00279227
- Acronym / sponsor ID
- EPICARD Study
- Conditions
- Coronary Artery Disease, Obesity
- Keywords
- coronary artery disease, epicardial adipose tissue, epicardial fat, obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Jan 2006
- Study completion
- Dec 2006
- First posted
- 19 Jan 2006 (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.
We sight to evaluate whether patients with coronary artery disease (CAD) have more epicardial fat than patients without CAD, which would suggest that epicardial fat may be more than an "innocent bystander" and be actively involved in the disease process. Its role as a modulator of vascular response and myocardial function could potentially lead to new areas of cardiac research. We also sight to evaluate whether epicardial fat from patients with CAD releases more adipokines than subcutaneous fat from these patients which could prompt studies into the differential regulation of adipokine secretion in this tissue. Thus for e.g., the use of thiazolidinediones (glitazones), statins, ARBs or other compounds that can specifically modulate adipokine secretion could be explored to determine their benefit in ameliorating the effects attributable to increased epicardial fat.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients elegible for elective cardiac surgery are elegible
- Ability to provide written informed consent in accordance with GCP guidelines and local legislations.
- > 18 years of age
Key exclusion criteria (2 listed)
- Control patients will not have clinical signs of CAD and will show normal coronary arteries on angiography.
- Any medical, social or geographic condition, which, in the opinion of the investigator would not allow safe or reliable completion of the protocol.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2006.
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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.
Arya M Sharma, MD, FRCPC principal investigator
McMaster University
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 and Obesity, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Aug 2006. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzana Damjanovic, MLT, CCRA (905-527-4322 ext. 44710, suzana@cardio.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 Aug 2006.