Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT02254668
Brief Summary:
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:
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)
Study:
NCT02254668
Study Brief:
Protocol Section:
NCT02254668