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

U

University Hospital, Clermont-Ferrand

Status and phase

Unknown
Phase 3

Conditions

Coronary Atherosclerosis

Treatments

Dietary Supplement: Omega 3

Study type

Interventional

Funder types

Other

Identifiers

NCT01699230
CHU-0120

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

30 participants in 2 patient groups

Omega 3 supplemented patients
Experimental group
Description:
To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis
Treatment:
Dietary Supplement: Omega 3
Control group
No Intervention group

Trial contacts and locations

1

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Central trial contact

Patrick LACARIN

Data sourced from clinicaltrials.gov

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