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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT00159159
Eligibility Criteria:
Inclusion Criteria:
Recipient:
* Males or females, ages \> 18 \< 65.
* First cardiac transplant.
* Negative pregnancy test for females of childbearing potential, at screening. Efficient method of contraception must be used during the study.
* Written informed consent.
Donor:
* Cold ischemia duration \< 6 hours
Exclusion Criteria:
Recipient:
* Unstable hemodynamic status at randomization.
* Patient with assisted circulation, considered unstable.
* Serum creatinine \> 250 µmol/l.
* Nursing or pregnant females.
* HIV positive.
* PCR hepatitis C virus (HCV) positive or hepatitis B surface (Hbs) antigen positive (within 6 months prior to study).
* Multi-organ graft or retransplant.
* History of cancer (evolving, or within 5 years, except for epidermoid or basocellular localised cutaneous carcinoma).
* Use of any investigational product and/or participation in another clinical research study within the last 30 days prior to study entry.
* Any substance abuse or any psychiatric disorder
* Contra-indication to study treatments.
* Unable to introduce ciclosporine within 4 days after transplant.
Donor:
* Known coronary pathology or cardiac disease.
* HBsAg positive or HCV positive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00159159
Study Brief:
Protocol Section:
NCT00159159