Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography (OCTandCAV)

September 29, 2014 updated by: University of Zurich

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

278

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich, Division of Cardiology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Templin, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Other: Protocol with Everolimus (Certican®)
Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®).
Other Names:
  • Randomizaiton by SecuTrial
Active Comparator: 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)
Other: Protocol with Mycophenolate mofetil (CellCept®)
Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®).
Other Names:
  • Randomizaiton by SecuTrial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intimal Thickness
Time Frame: Assessment intervals of patients with CAV is 1 year and 2 years in patients without CAV
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Christian Templin, MD, PhD, University Hospital Zurich (Switzerland), Division of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

December 29, 2013

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

October 2, 2014

Study Record Updates

Last Update Posted (Estimate)

October 2, 2014

Last Update Submitted That Met QC Criteria

September 29, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH_Nr. 2012-0409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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