Potential Effects of Omega 3 Supplementation on Cardiomyocytes Membranes for Patients With Coronary Atherosclerosis? (CORONOMEGA3)

October 1, 2012 updated by: University Hospital, Clermont-Ferrand
To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Very few human data are currently available on the fatty acid composition of cardiomyocytes membranes. Preoperative omega-3 supplementation for patients undergoing cardiac surgery with cardiopulmonary bypass is correlated with a decreased frequency of postoperative complications in type of arrhythmia atrial fibrillation. Atrial fibrillation is the most common complication: 30 to 50% after myocardial revascularization. The occurrence of atrial fibrillation increases morbidity and mortality after surgery for sure. The pathophysiological mechanisms of common atrial fibrillation treated in heart rhythm units are different from those of postoperative atrial fibrillation. Indeed, atrial fibrillation is a common disease primarily of the left atrium, although atrial fibrillation after cardiac surgery is a multifactorial disease with implication of various pathogens such as inflammation without precise anatomical support. The preventive use of polyunsaturated fatty acids omega-3 long-chain (LC-AGPIω3), prior cardiac surgery is far from widespread due to a Lack of information dissemination, by insufficient number of published studies, despite the existence of a number of ongoing clinical trials and a complete ignorance of biological mechanisms of action. A human clinical study is needed. In a context of cardiac surgery with cardiopulmonary bypass and without deleterious side effects of preoperative enrichment in omega-3, it seems appropriate to conduct a feasibility study to provide information on structural changes in membranes of cardiomyocytes.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men without diabetes,
  • over 50 years with overweight (BMI greater than 25) and
  • without severe obesity (BMI less than 40)
  • Patients who have given their written consent,
  • the beneficiary of a social security system.
  • Elective cardiac surgery with sternotomy and cardiopulmonary bypass for coronary artery bypass graft.

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
EXPERIMENTAL: Omega 3 supplemented patients
To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis
Dietary supplement: Omega 3
To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fatty acid variations
Time Frame: at J-21
at J-21

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative arrhythmias (atrial fibrillation)
Time Frame: at J-21, J0, J7 and J30
at J-21, J0, J7 and J30
postoperative inflammatory syndrome
Time Frame: at J-21, J0, J7 and J30
at J-21, J0, J7 and J30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Université d'Auvergne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2013

Study Completion (ANTICIPATED)

May 1, 2013

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (ESTIMATE)

October 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 1, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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