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

NCT02254668 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2014-10-02

No results posted yet for this study

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.

Conditions

  • Intimal Proliferation
  • Immunosuppression

Interventions

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®).

Sponsors & Collaborators

Principal Investigators

  • Christian Templin, MD, PhD · University Hospital Zurich (Switzerland), Division of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Switzerland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02254668 on ClinicalTrials.gov