Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography

Study Overview
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Brief Summary
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Randomized prospective multi-center imaging study which investigates the impact of different immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on cardiac allograft vasculopathy (CAV) in heart transplanted patients. Maximal intima-thickness will be visualized by optical coherence tomography (OCT) to assess the progression of CAV.

Detailed Description
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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 divided in three sections: Substudy 1: Evaluation of morphological differences between between CAD and CAV. Substudy 2: Analysis of cardiovascular risk factors (e.g. hypertension) under a specific immunosuppressive protocol in patients with CAV. Substudy 3: Prospective, randomized analysis of the influence of different immunosuppressive protocols in patients with CAV. Primary endpoint of the study will be the adaption of intimal thickness after 10 years, analysed by means of optical coherence tomography. In addition to the explanations above the most important in- and exclusion criteria are listed below: Inclusion Criteria: Patients after heart transplantation Patients with coronary artery disease (CAD) Age 18-80 years Exclusion Criteria: Contraindication of Everolimus/Sirolimus or adjuvants Renal insufficiency (Creatinine > 265 µmol/l) Cardiogenic shock or patients with Killip*-Class III or IV (*name) Pregnant or breast feeding females insufficient contraception (only for substudy 3)

Official Title
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Intracoronary Analysis of Cardiac Allograft Vasculopathy in Comparison to Coronary Artery Disease by Means of Optical Coherence Tomography

Conditions
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Intimal Proliferation, Immunosuppression

Intervention / Treatment
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* Other: Protocol with Everolimus (Certican®)
* Other: Protocol with Mycophenolate mofetil (CellCept®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with heart transplantation Patient with coronary artery disease Age between 18 and 80 years Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Everolimus (Certican®)<br>Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®). No protocol with Mycophenolate mofetil (CellCept®). Daily dosage administered depending on blood concentration (control interval 6-12 months) | Other: Protocol with Everolimus (Certican®)<br>* Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®).<br>* Other names: Randomizaiton by SecuTrial;|
| Active Comparator: Mycophenolate mofetil (CellCept®)<br>Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®). No protocol with Everolimus (Certican®). Daily dosage administered depending on blood concentration (control interval 6-12 months) | Other: Protocol with Mycophenolate mofetil (CellCept®)<br>* Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®).<br>* Other names: Randomizaiton by SecuTrial;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intimal Thickness | Assessment is usually performed by intracoronary angiography and endomyocardial biopsy which is routinely performed <1 year after heart transplantation. Furthermore, assessment interval will be defined according to the result of these investigational procedures. If there is a diagnosis of CAV the interval will be one year, if not a follow-up examination in two years will be sufficient. | Assessment intervals of patients with CAV is 1 year and 2 years in patients without CAV | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thickness, transplantation, cardiology, intima, immunosuppression