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

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ClinicalTrials.gov Identifier: NCT01699230
Recruitment Status : Unknown
Verified October 2012 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : October 3, 2012
Last Update Posted : October 3, 2012
Sponsor:
Collaborator:
Université d'Auvergne
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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

Condition or disease Intervention/treatment Phase
Coronary Atherosclerosis Dietary Supplement: Omega 3 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Potential Effects of Omega 3 Supplementation on Cardiomyocytes Membranes for Patients With Coronary Atherosclerosis?
Study Start Date : March 2011
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
No Intervention: Control group



Primary Outcome Measures :
  1. fatty acid variations [ Time Frame: at J-21 ]

Secondary Outcome Measures :
  1. postoperative arrhythmias (atrial fibrillation) [ Time Frame: at J-21, J0, J7 and J30 ]
  2. postoperative inflammatory syndrome [ Time Frame: at J-21, J0, J7 and J30 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699230


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Université d'Auvergne
Investigators
Principal Investigator: Kasra AZARNOUSH University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01699230     History of Changes
Other Study ID Numbers: CHU-0120
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012

Keywords provided by University Hospital, Clermont-Ferrand:
Elective cardiac surgery
with sternotomy and
cardiopulmonary bypass
for coronary artery
bypass graft.

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases