Status:
TERMINATED
Endothelial Injury and Development of Coronary Intimal Thickening After Heart Transplantation
Lead Sponsor:
Gladwin, Mark, MD
Conditions:
Cardiac Allograft Vasculopathy
Antibody Mediated Rejection
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
Coronary allograft vasculopathy (CAV) is the leading cause of late graft failure and second leading cause of late mortality after heart transplantation. CAV has been associated with a variety of tradi...
Eligibility Criteria
Inclusion
- Subjects who are 1 year post heart transplantation
- Subjects will include both male and females
- Be at least 18 years of age
Exclusion
- Known coronary artery disease after transplantation
- Evidence of strong or moderate antibodies already present at the time of the transplant
- Severe renal dysfunction defined as creatinine clearance of \<30 or on hemodialysis.
- 3 or more episodes of acute cellular rejection
- Females who are pregnant
- Patients requiring endomyocardial biopsy at the time of catheterization
- Patients unable to tolerate heparin or systemic anticoagulation
- History of multi-organ transplant
- Patients unable to give consent
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01848301
Start Date
September 1 2012
End Date
May 1 2017
Last Update
September 6 2017
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213