Prevalence and Prognostic Value of Unrecognised Myocardial Injury in Stable Coronary Artery Disease (PUMI)- a Multicenter, Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 275
- 试验地点
- 6
- 主要终点
- Cardiac events defined as a composite of death, resuscitated cardiac arrest, spontaneous acute myocardial infarction and hospitalisation for congestive heart failure or unstable angina.
研究概览
简要总结
This study includes patients with stable coronary artery disease without previously known myocardial infarction, and investigates the prevalence of clinically unrecognized myocardial damage and its prognostic implication.
详细描述
A substantial portion of all myocardial infarctions are not clinically recognized, but the myocardial damage can be recognized afterwards e g by magnetic resonance imaging (MRI). This study includes patients with stable coronary artery disease without previously known myocardial infarction, and investigates the prevalence of clinically unrecognised myocardial damage (UMI), and the prognostic value of UMI regarding new cardiac events.
In a subset of the patients, the biologic intra-individual variability of troponin and other biochemical markers will be investigated (substudy protocol).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptoms of stable angina pectoris according to the treating physician
- •scheduled for coronary angiography
- •written informed consent
排除标准
- •pathological Q-wave in the 12-lead resting ECG
- •known previous myocardial infarction
- •previous PCI (percutaneous coronary intervention) or CABG (coronary artery bypass graft)
- •history of congestive heart failure
- •anything that contraindicates a MRI investigation (e.g. pacemaker, claustrophobia, intracranial clips)
- •lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
结局指标
主要结局
Cardiac events defined as a composite of death, resuscitated cardiac arrest, spontaneous acute myocardial infarction and hospitalisation for congestive heart failure or unstable angina.
时间窗: 24 months
次要结局
- Degree and localization of artherosclerotic lesions at a coronary angiogram(Baseline)
- Presence of unrecognized myocardial infarction(Baseline)
- Size and localisation of unrecognized myocardial infarction(Baseline)
- Procedure related acute myocardial infarction(5 years)
- Left ventricular mass and dimensions, levels of troponin and other biochemical markers, electrocardiography (ECG), anthropometric data(Baseline)
- Long-term mortality, cardiac mortality and incidence of acute myocardial infarction(5 years)