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临床试验/NCT02313038
NCT02313038已完成不适用

Prospective Assessment of Efficacy and Safety of Drug Eluting Stents

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 6,023 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6,023
试验地点
1
主要终点
Composite of major adverse cardiac events (MACE)

研究概览

简要总结

Coronary heart disease (CHD) pose a serious health threat to population. PCI using drug eluting stents (DES), as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the real-life DES use and the efficacy and safety in China is limited. By consecutively recruiting first-ever PCI patients in 30 geographically representative highest-rank hospitals, this study will examine the prognosis in groups with different brands of DES, and various real-life factors, that may affect patients recovery after the procedure. Evidence for clinical practice and health resource allocation will be established based on the findings, to improve patients outcomes in future finally.

详细描述

In this study, 6000 patients who underwent the first-ever drug eluting stents (DES) deployment during the index hospitalization will be consecutively recruited in 30 tertiary hospitals scattered all over China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. And CAG imaging will be reviewed by national and international expert panels. At 1 month, 6 month, and 12 month after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. At 1-Month and 12-Month follow-up visit, blood and urine sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine the prognosis in groups with different brands of DES, and various real-life factors, that may affect patients recovery after the procedure. Evidence for clinical practice and health resource allocation will be established based on the findings, to improve patients outcomes in future finally.

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

入选标准

  • At least one DES is implanted successfully in the procedure
  • Only one of the five major brands of DES is used in the procedure

排除标准

  • Prior stent implantation history

结局指标

主要结局

Composite of major adverse cardiac events (MACE)

时间窗: 1 year

Composite of major adverse cardiac events (MACE) including death, myocardial infarction, and/or revascularization.

次要结局

  • Quality of life(1 year)
  • Safety endpoint(1 year)
  • Symptoms status(1 year)
  • Cost-effectiveness(1 year)
  • Efficacy composite endpoints(1 year)
  • Status of general health(1 year)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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