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

This study is currently recruiting participants.
Verified October 2012 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborator:
Human Nutrition Unit UMR1019 Université d'Auvergne - INRA
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01699230
First received: July 13, 2012
Last updated: October 1, 2012
Last verified: October 2012

July 13, 2012
October 1, 2012
March 2011
May 2013   (final data collection date for primary outcome measure)
fatty acid variations [ Time Frame: at J-21 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01699230 on ClinicalTrials.gov Archive Site
  • postoperative arrhythmias (atrial fibrillation) [ Time Frame: at J-21, J0, J7 and J30 ] [ Designated as safety issue: Yes ]
  • postoperative inflammatory syndrome [ Time Frame: at J-21, J0, J7 and J30 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Potential Effects of Omega 3 Supplementation on Cardiomyocytes Membranes for Patients With Coronary Atherosclerosis?
Potential Effects of Omega 3 Supplementation on Cardiomyocytes Membranes for Patients With Coronary Atherosclerosis?

To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Coronary Atherosclerosis
Dietary Supplement: Omega 3
To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis
  • Experimental: Omega 3 supplemented patients
    To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis
    Intervention: Dietary Supplement: Omega 3
  • No Intervention: Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
May 2013
May 2013   (final data collection date for primary outcome measure)

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:

Male
50 Years and older
No
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
France
 
NCT01699230
CHU-0120
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Human Nutrition Unit UMR1019 Université d'Auvergne - INRA
Principal Investigator: Kasra AZARNOUSH University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP