Strategies To Prevent Cardiac Allograft Vasculopathy Related Events in Heart Transplant Recipients (STOPCAV)
Cardiac Allograft Vasculopathy
About this trial
This is an interventional prevention trial for Cardiac Allograft Vasculopathy focused on measuring Cardiac Allograft Vasculopathy in Heart Transplant
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
Sites / Locations
- Cardiology Division, University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Early Intervention Arm
Late Intervention Arm: Group 2A
Retrospective Arm: Angiogram group
Late Intervention Arm: Group 2B
Retrospective Arm: Intravascular Ultrasound
Initiate sirolimus within 6 months of heart transplant
Initiate sirolimus after CAV is diagnosed by angiogram
Start sirolimus after CAV diagnosed is by angiogram
Start sirolimus after CAV is diagnosed by IVUS
Sirolimus after CAV is diagnosed by IVUS