Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT00446966
Eligibility Criteria:
Inclusion Criteria:
* Age 18-85 years old.
* Elective coronary artery bypass (CABG) operation with or without concomitant valve surgery planned for at least 2 days after enrollment.
* Signed, documented informed consent prior to admission to the study.
Exclusion Criteria:
* Urgent or emergent bypass required to be performed \<24 hrs after screening.
* Unstable angina, requiring intervention or CABG \<24 hrs after screening.
* Decompensated congestive heart failure.
* Chronic, persistent atrial fibrillation - patient in atrial fibrillation at the time of screening or enrollment or scheduled for a maze procedure or pulmonary vein isolation at the time of surgery.
* Known sensitivity to Omacor (0mega-3 acid ethyl esters) and hypersensitivity to fish, fish products or corn oil.
* Patients requiring warfarin or Lovenox the 2 days prior to bypass surgery.
* Patients on Class I or III antiarrhythmic agents (quinidine, procainamide, disopyramide, flecainide, propafenone, moricizine, dofetilide, sotalol, amiodarone) or who have taken these drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone).
* Patients who are pregnant or nursing.
* Patients unable to provide/sign informed consent.
* Patients currently enrolled in another clinical trial without a 30 day washout period.
* Patients currently taking marine based omega-three fish oil supplements.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00446966
Study Brief:
Protocol Section:
NCT00446966