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

Immunosuppression Clinical Trial

— OCTandCAV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02254668
• Other study ID #: KEK-ZH_Nr. 2012-0409
• Status: Recruiting
• Phase: Phase 4
• First received: December 29, 2013
• Last updated: September 29, 2014
• Start date: December 2013
• Est. completion date: February 2023

Study information

• Verified date: September 2014
• Source: University of Zurich
• Contact: Christian Templin, MD, PhD
• Phone: +41 (0)44 / 255 9585
• Email: christian.templin[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 278
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunosuppression
• Intimal Proliferation

Intervention

Other:
• 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®).

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Cardiology	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   Information about heart transplantation at University Hospital of Zurich
•   Informations about Optical Coherence Tomography (OCT)