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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
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
  Purpose

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


Condition Intervention Phase
Coronary Atherosclerosis
Dietary Supplement: Omega 3
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Potential Effects of Omega 3 Supplementation on Cardiomyocytes Membranes for Patients With Coronary Atherosclerosis?

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • fatty acid variations [ Time Frame: at J-21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Human Nutrition Unit UMR1019 Université d'Auvergne - INRA
Investigators
Principal Investigator: Kasra AZARNOUSH University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01699230     History of Changes
Other Study ID Numbers: CHU-0120
Study First Received: July 13, 2012
Last Updated: October 1, 2012
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 29, 2014