Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography
NCT ID: NCT02254668
Last Updated: 2014-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
278 participants
INTERVENTIONAL
2013-12-31
2023-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Everolimus (Certican®)
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)
Protocol with Everolimus (Certican®)
Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®).
Mycophenolate mofetil (CellCept®)
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)
Protocol with Mycophenolate mofetil (CellCept®)
Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®).
Interventions
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Protocol with Everolimus (Certican®)
Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®).
Protocol with Mycophenolate mofetil (CellCept®)
Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with coronary artery disease
* Age between 18 and 80 years
Exclusion Criteria
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Christian Templin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zurich (Switzerland), Division of Cardiology
Locations
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University Hospital Zurich, Division of Cardiology
Zurich, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Informations about Optical Coherence Tomography (OCT)
Other Identifiers
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KEK-ZH_Nr. 2012-0409
Identifier Type: -
Identifier Source: org_study_id
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