NCT04791852已完成不适用
Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy
Puerta de Hierro University Hospital1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2019年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Performance of the biomarker for the diagnosis of CAV
研究概览
简要总结
Cross-sectional study. We will prospectively obtain ddcf-DNA levels in all patients who undergo routine coronary angiography > 1 year after HT. Our main goal is to evaluate the performance of Donor-derived Cell Free DNA (ddcf-DNA) as a biomarker of CAV.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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 over 18 and under 80 years old, HT > 1 year ago
排除标准
- •Patients under 18 or over 80 years old
- •Multiorgan transplant
- •History of acute cellular rejection ≥ 1R or antibody mediated rejection in the previous 6 months
- •Concomitant infection by CMV
结局指标
主要结局
Performance of the biomarker for the diagnosis of CAV
时间窗: 2 years
Determine the performance of this biomarker in this situation using receiver-operator characteristics analysis.
Correlation between ddcf-DNA and CAV
时间窗: 2 years
Correlation between ddcf-DNA levels and the presence of any degree of CAV (CAV0 vs CAV1, 2, or 3)
次要结局
- Correlation of ddcf-DNA with the different degrees of CAV (0, 1, 2 and 3)(2 years)
- Correlation of ddcf-DNA with other biomarkers (NTproBNP and troponin I)(2 years)
研究者
Javier Segovia Cubero
Head of Cardiology Department
Puerta de Hierro University Hospital
研究点 (1)
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