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

NCT02254668 | Unknown Phase 4 DMC

• 1 other identifier: KEK-ZH_Nr. 2012-0409
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

Intimal Proliferation; Immunosuppression

Keywords

intima; thickness; transplantation; cardiology; immunosuppression

Outcome Measures

Primary Outcomes (1)

• Intimal Thickness

  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

Study Arms (2)

Everolimus (Certican®)

EXPERIMENTAL

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®)

Mycophenolate mofetil (CellCept®)

ACTIVE COMPARATOR

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®)

Interventions

Protocol with Everolimus (Certican®) OTHER

Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®).

Also known as: Randomizaiton by SecuTrial

Everolimus (Certican®)

Protocol with Mycophenolate mofetil (CellCept®) OTHER

Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®).

Also known as: Randomizaiton by SecuTrial

Mycophenolate mofetil (CellCept®)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with heart transplantation
• Patient with coronary artery disease
• Age between 18 and 80 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University Hospital Zurich, Division of Cardiology

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Links

• Informations about Optical Coherence Tomography (OCT)

MeSH Terms

Interventions

Clinical Protocols; Everolimus; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Sirolimus; Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Christian Templin, MD, PhD

  University Hospital Zurich (Switzerland), Division of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Templin, MD, PhD

CONTACT

+41 (0)44 / 255 9585; christian.templin@usz.ch

Frank Ruschitzka, Professor

CONTACT

+41 (0)44 / 255 3957; frank.ruschitzka@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2013
• First Posted: October 2, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: October 2, 2014

Record last verified: 2014-09

Locations

CH (1)