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)12 个研究点分布在 1 个国家目标入组 178 人2014年10月

适应症Cardiac Transplantation

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Cardiac Transplantation
发起方: National Institute of Allergy and Infectious Diseases (NIAID)
入组人数: 178
试验地点: 12
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
状态: 已完成
最后更新: 10年前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2014年10月

结束日期

2015年6月

最后更新

10年前

研究类型

Observational

性别

All

研究者

发起方

National Institute of Allergy and Infectious Diseases (NIAID)

责任方

Sponsor

入排标准

入选标准

•Subjects previously enrolled in the CTOT-05 study
•Subjects 4 years post-transplant (+/- 6 months).

排除标准

•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)