Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- XDx
- 入组人数
- 800
- 试验地点
- 17
- 主要终点
- Acute Cellular Rejection(ACR)grades - ACR ISHLT Grades will be determined by centralized pathology reading. The associated AlloMap Test score will be correlated to the biopsy reading.
研究概览
简要总结
The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to provide independent evidence of the clinical performance of the non-invasive AlloMap test. Sensitive detection of cardiac allograft rejection and dysfunction is the basis for successful recipient management. The CARGO II Study will assess the correlation between the presence or absence of acute cellular rejection as determined by examination of endomyocardial biopsy specimens with results from the AlloMap Test. Of 17 participating transplant centers, 4 are in North America and 13 are in Europe.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •New and existing allograft recipients
- •All patients (age ≥ 18years) receiving post-transplant care at the enrolling centers
排除标准
- •Concurrent enrollment in a double-blind drug trial (immunosuppressive drugs).
结局指标
主要结局
Acute Cellular Rejection(ACR)grades - ACR ISHLT Grades will be determined by centralized pathology reading. The associated AlloMap Test score will be correlated to the biopsy reading.
时间窗: Scheduled clinic visit
次要结局
- Evaluation of the AlloMap Test and novel gene expression algorithm in guiding management of steroids and calcineurin inhibitors based on the algorithm's capacity to predict future cellular rejection and future graft dysfunction.(more than 2 months following date of transplant)
- Assessment of clinical utility of the AlloMap Test and novel gene expression algorithms in diagnosis and prediction of humoral rejection.(>2 months after date of transplant)