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临床试验/NCT01233336
NCT01233336已完成不适用

Hepatocyte Growth Factor as an Early Marker of Myocardial Injury and Prognostic Factor of Cardiovascular Events in Log-term Follow up in Patients With Acute Coronary Syndrome

National Institute of Cardiology, Warsaw, Poland1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2010年7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
45
试验地点
1
主要终点
composite end point

研究概览

简要总结

This is the continuation of previous study (registration number: NCT00844987) which revealed that hepatocyte growth factor (HGF) is a very early, good marker of myocardial injury and prognostic factor for post myocardial infarction (MI) cardiovascular events presence in long-term follow-up. Due to potentially very important implication of the results of previous study it was decided to continue research of HGF in patients with MI. Now, is scheduled to examine 100 consecutive patients with STEMI. HGF assessments will be performed just after admission to hospital, 1h and 24h later and before discharge. Two follow-up visits were planned i.e. at 3 and 6 months after MI. During hospitalization and at 6 month visit the echocardiography examination will be performed. The composite primary endpoint consists of cardiovascular events observed during hospital course and in long term-follow-up.

详细描述

Hepatocyte growth factor (HGF) was examined in study number NCT00844987 as a potentially useful marker of acute myocardial injury. Results of the study confirmed efficacy of HGF as very early marker of myocardial necrosis and as a prognostic factor for cardiovascular events in long term follow up. Recent study is a continuation of previous study.

The aim is to confirm that maximal values of the HGF in first examination performed in ACS (acute coronary syndrome) patients and to show predictive value of HGF for early and late outcome in patients with ACS.

Materials and method: 100 patients with acute coronary syndrome will be included into the study. HGF will be examined four times i.e. just after admission, 1h and 24h latter and before discharge. In case of 10 patients will be performed 10 assessments during first day of ACS.

The follow up visits will take place 3 and 6 months after ACS. During hospitalization and 6 months later echocardiography examination will be performed and the extension of heart dysfunction will be assessed. Control group will consist of 10-15 health volunteers.

The primary endpoint is a composite endpoint which will include following cardiovascular events observed during hospitalization and during 6-month follow up: death, reinfarction, coronary interventions (PCI and/or CABG) due to new ACS or exacerbation of angina, symptoms of heart failure, rehospitalization due to cardiovascular events and stroke in context of HGF concentration in acute stage of ACS.

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,
  • chest pain,
  • symptoms of ischemia at ECG,
  • signed informed consent form

排除标准

  • age < 18 years,
  • not signed informed consent form.

结局指标

主要结局

composite end point

时间窗: 6-month follow -up

death, reinfarction, coronary interventions (PCI and/or CABG) due to new ACS or exacerbation of angina, symptoms of heart failure, rehospitalisation due to cardiovascular events and stroke in context of HGF concentration in acute stage of ACS

次要结局

  • symptoms of heart failure(6-month follow-up)
  • death(6- month follow-up)
  • rehospitalisation due to cardiovascular reasons(6- month follow-up)

研究者

发起方
National Institute of Cardiology, Warsaw, Poland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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