Status:
COMPLETED
Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients
Lead Sponsor:
Bryan Goldstein
Conditions:
Orthotopic Heart Transplant
Eligibility:
All Genders
1-25 years
Phase:
PHASE3
Brief Summary
Heart transplantation is a life-sustaining therapy that allows patients with either congenital or acquired heart disease and severe cardiac dysfunction to survive. Over time, however, the transplanted...
Eligibility Criteria
Inclusion
- Patients age 1 - 25 years who are status-post OHT (≤18 years at the time of transplantation) and undergoing routine post-transplant surveillance catheterization for endomyocardial biopsy and coronary angiography
Exclusion
- The presence of sick sinus syndrome or 2nd or 3rd degree atrioventricular block (without a functioning implanted pacemaker)
- Hemodynamically significant valvular disease
- Severe asthma or bronchospasm, known severe CAV
- Pulmonary hypertension.
- Patients taking digoxin
- Verapamil and dipyridamole are also excluded given known interactions with adenosine.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03231371
Start Date
November 1 2008
End Date
January 1 2011
Last Update
September 26 2017
Active Locations (1)
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1
University of MIchigan-Congenital Heart Center
Ann Arbor, Michigan, United States, 48109