A Phase 3 interventional study of Omega 3 in Coronary Atherosclerosis, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-10-03.
Sponsored by University Hospital, Clermont-Ferrand · Phase 3 and Interventional
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.
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's planned enrollment of 30 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
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
fatty acid variations
Time frame: at J-21
postoperative arrhythmias (atrial fibrillation)
Time frame: at J-21, J0, J7 and J30
postoperative inflammatory syndrome
Time frame: at J-21, J0, J7 and J30
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University Hospital, Clermont-Ferrand