NCT01699230

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

October 3, 2012

Status Verified

October 1, 2012

Enrollment Period

2.2 years

First QC Date

July 13, 2012

Last Update Submit

October 1, 2012

Conditions

Coronary Atherosclerosis

Keywords

Elective cardiac surgerywith sternotomy andcardiopulmonary bypassfor coronary arterybypass graft.

Outcome Measures

Primary Outcomes (1)

  • fatty acid variations

    at J-21

Secondary Outcomes (2)

  • postoperative arrhythmias (atrial fibrillation)

    at J-21, J0, J7 and J30

  • postoperative inflammatory syndrome

    at J-21, J0, J7 and J30

Study Arms (2)

Omega 3 supplemented patients

EXPERIMENTAL

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

Dietary Supplement: Omega 3

Control group

NO INTERVENTION

Interventions

Omega 3DIETARY_SUPPLEMENT

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

Omega 3 supplemented patients

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Kasra AZARNOUSH

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2012

First Posted

October 3, 2012

Study Start

March 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

October 3, 2012

Record last verified: 2012-10

Locations

FR(1)