Status:
UNKNOWN
Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Intimal Proliferation
Immunosuppression
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Randomized prospective multi-center imaging study which investigates the impact of different immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on cardiac allogr...
Detailed Description
In summary, the aim of the study is to examine the effect of the immunosuppressive agent Everolimus (Certican) on the development of cardiac allograft vasculopathy (CAV). Therefore the study is divid...
Eligibility Criteria
Inclusion
- Patients with heart transplantation
- Patient with coronary artery disease
- Age between 18 and 80 years
Exclusion
- Renal insufficiency (\> 265 µmol/l)
- Incapability to give informed consent
- Cardiogenic shock of patient with KILLIP III or IV
- pregnant or breast feeding females
- insufficient contraception (only for substudy 3)
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT02254668
Start Date
December 1 2013
End Date
February 1 2023
Last Update
October 2 2014
Active Locations (1)
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1
University Hospital Zurich, Division of Cardiology
Zurich, Canton of Zurich, Switzerland, 8091