Intracoronary Analysis of Cardiac Allograft Vasculopathy in Comparison to Coronary Artery Disease by Means of Optical Coherence Tomography
试验速览
- 阶段
- 4 期
- 入组人数
- 278
- 试验地点
- 2
- 主要终点
- Intimal Thickness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with heart transplantation
- •Patient with coronary artery disease
- •Age between 18 and 80 years
排除标准
- •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)
研究组 & 干预措施
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)
干预措施: Protocol with Everolimus (Certican®) (Other)
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)
干预措施: Protocol with Mycophenolate mofetil (CellCept®) (Other)
结局指标
主要结局
Intimal Thickness
时间窗: 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.
次要结局
未报告次要终点