NCT02254668

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 278 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Intimal Proliferation
• Immunosuppression

Interventions

Type	Name	Description
OTHER	Protocol with Everolimus (Certican®)	Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®).
OTHER	Protocol with Mycophenolate mofetil (CellCept®)	Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®).

Timeline

• Start date: 2013-12-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2014-10-02
• Last updated: 2014-10-02

Locations

1 site across 1 country: Switzerland