Clinical trial NCT02254668: Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography
Official title: Intracoronary Analysis of Cardiac Allograft Vasculopathy in Comparison to Coronary Artery Disease by Means of Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intimal Proliferation
Immunosuppression
Keywords: intima
thickness
transplantation
cardiology
immunosuppression
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2014-10-02
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Intimal Thickness
timeFrame: Assessment intervals of patients with CAV is 1 year and 2 years in patients without CAV
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Cardiology
Study officials:
affiliation: University Hospital Zurich (Switzerland), Division of Cardiology
name: Christian Templin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: