NCT02255123已完成不适用
A Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study (CTOT-18)
National Institute of Allergy and Infectious Diseases (NIAID)24 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 24
- 主要终点
- Composite incidence of Death, Re-transplantation or re-listed for transplantation, Coronary stent, Myocardial Infarction and Clinical evidence of CAV per ISHLT grading
研究概览
简要总结
This study is a multicenter, non-randomized, retrospective study to collect long term (4 years post-transplant) clinical outcome data on subjects previously enrolled in the CTOT-05 study (NCT00466804) to evaluate participant and graft survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects previously enrolled in the CTOT-05 study
- •Subjects 4 years post-transplant (+/- 6 months).
排除标准
- •1. Withdrawal of consent from the CTOT-05 study.
结局指标
主要结局
Composite incidence of Death, Re-transplantation or re-listed for transplantation, Coronary stent, Myocardial Infarction and Clinical evidence of CAV per ISHLT grading
时间窗: 48 months (+/- 6 months) after primary transplantation
Coronary Artery Vasculopathy (CAV) International Society for Heart and Lung Transplantation Registry (ISHLT)
次要结局
- Incidence of clinical evidence of CAV per ISHLT grading(48 months (+/- 6 months) after primary transplantation)
- Incidence of death(48 months (+/- 6 months) after primary transplantation)
- Incidence of re-transplantation or re-listed for transplantation(48 months (+/- 6 months) after primary transplantation)
- Incidence of myocardial infarction(48 months (+/- 6 months) after primary transplantation)
- Incidence of coronary stent(48 months (+/- 6 months) after primary transplantation)
研究者
研究点 (24)
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