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:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT01072994
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75 years of age at time of cardiac transplantation;
2. Absence of cardiac allograft rejection on the index cardiac biopsy
3. No treatment for cardiac allograft rejection within 30 days of enrollment
4. Absence of restrictive physiology or cardiac allograft dysfunction on hemodynamic assessment
5. Stable immunosuppression and other background medications for past 30 days with no planned modulation in therapy for 6 months
6. All women of childbearing potential must have a negative urine pregnancy test prior to treatment and agree to use adequate contraception (defined as oral or injectable contraceptives, intrauterine devices, surgical sterilization or a combination of a condom and spermicide) or limit sexual activity to vasectomized partner for 3 months after administration of therapy;
7. Ability to sign Informed Consent Form and Release of Medical Information Form
Exclusion Criteria:
1. Regular use of u)-3 PUFA supplements (fish oil or flax seed oil).
2. Alcoholism or drug abuse;
3. Poorly controlled diabetes (defined as a Hb A1C \>8);
4. Fasting triglycerides \>250 mg/dl.
5. Pregnancy and Lactation
6. Persons with known sensitivity or allergy to fish;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01072994
Study Brief:
Protocol Section:
NCT01072994