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 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT01305395
Eligibility Criteria:
Inclusion Criteria
For Prospective Arm:
* 18 years or older
* Successful orthotropic heart transplant within 6 months of enrollment
Inclusion Criteria
For Retrospective Arm:
* 18 years or older
* Successful orthotropic heart transplant within 6 months to 3 years of enrolment
* Less than moderate CAV by angiogram or IVUS
Exclusion Criteria
For Prospective Arm:
* Greater than minimal baseline coronary disease
* Chronic kidney disease with creatinine \>2mg/dl
* Baseline (1 month) ejection fraction \< 50%
* IV contrast allergy
* Rejection within 3 months of enrollment
* Sensitivity to sirolimus or its derivatives
* Prior sirolimus use
Exclusion Criteria
For Retrospective Arm:
* Significant baseline (one month) coronary artery disease (\>50% in one or more vessels by angiogram or MIT \>0.5 by IVUS)
* Chronic kidney disease with creatinine \>2mg/dl
* Baseline (1 month) ejection fraction \< 50%
* IV contrast allergy
* Rejection within 3 months prior to enrollment
* Sensitivity to sirolimus or its derivatives
* Prior sirolimus use
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01305395
Study Brief:
Protocol Section:
NCT01305395