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临床试验/NCT03297164
NCT03297164已完成不适用

One Year Incidence Rate of Heart Failure After Acute Myocardial Infarction With Optimal Treatment-A Prospective,Multicenter,Cohort Study

Harbin Medical University19 个研究点 分布在 1 个国家目标入组 12,043 人开始时间: 2017年12月21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
12,043
试验地点
19
主要终点
incidence rate of heart failure

研究概览

简要总结

The main purpose of this study is to build a multi-center, prospective and regionally representative acute myocardial infarction(AMI) cohort,and build a study platform for heart failure caused by AMI; To explore the 1 year incidence rate of heart failure after AMI given the optimized treatment and the treatment model affecting the incidence rate of heart failure, and finally to reduce the incidence rate of heart failure by 5%.

详细描述

the study aim to enroll 12000 acute myocardial infartion (AMI) patients, including ST-segment elevation myocardial infarction (STEMI) and non ST-segment elevation myocardial infarction (NSETMI), Patients were divided into two groups(optimized group and un-optimized group) according to treatment models they accepted in 20 reginally representative hosptials of China. whether optimizaed or not is judged by 4 four aspects,including emergency treatment procedure, pre-infusion medication, reperfusion strategy selection, and early rehabilitation after reperfusion.Patients were followed at 1 month, 6 months and 12 months. The physical condition and clinical events(heart failure, death, re-infarction, revascularization, apoplexy, malignant arrhythmias, bleeding events, other adverse events)were collected at follow up.

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

  • age≥18 years
  • diagnosed acute myocardial infarction
  • signed the informed consent form

排除标准

  • AMI is caused by surgery, trauma, gastrointestinal bleeding or complications of PCI;
  • AMI occurred in patients who have been hospitalized for other reasons;
  • patients with previous history of chronic heart failure;
  • researchers judging that patient's compliance was poor and could not complete the study according to the requirements.
  • life expectancy is less than 12 months;
  • heart transplant patients;
  • patients with tumors;

结局指标

主要结局

incidence rate of heart failure

时间窗: 12th month after diacharge

incidence rate of heart failure of acute myocardial infarction at 12th month

次要结局

  • MACCE rate(12th month after diacharge)
  • bleeding rate(12th month after diacharge)
  • severe adverse drug reactions(12th month after diacharge)

研究者

发起方
Harbin Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu Bo

director

Harbin Medical University

研究点 (19)

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