Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-30 @ 1:27 AM
Study NCT ID:
NCT02254668
Status:
UNKNOWN
Last Update Posted:
2014-10-02
First Post:
2013-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
Intracoronary Analysis of Cardiac Allograft Vasculopathy in Comparison to Coronary Artery Disease by Means of Optical Coherence Tomography
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCTandCAV
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)
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: