RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients - an Observational Study (REBUS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 425
- 试验地点
- 1
- 主要终点
- Death, myocardial infarction, stroke
研究概览
简要总结
The study is an open, single center, observational study at the Cardiology Dept at Uppsala University Hospital. The number of patients included will be 410. The objectives are to:
Evaluate biomarkers and change of these related to myocardial infarction, during two years follow-up in an unselected patient population with a recent myocardial infarction.
Evaluate if an early change of biomarkers can be related to death, new myocardial infarction, and ischemic stroke in the same population after two and five years follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myocardial infarction diagnosed by dynamic raised troponin I with at least one value above 0.1 µg/L. Together with at least one of the criteria; symptoms suggestive for myocardial infarction or development of significant Q wave.
- •Treated at the Department of cardiology, Uppsala University Hospital.
- •Ability to attend the scheduled visits for evaluation procedures.
- •Signed Informed Consent.
排除标准
- •Death ≤ 5 days after the myocardial infarction.
- •Not belonging to the catchment area of Uppsala University Hospital.
- •Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
结局指标
主要结局
Death, myocardial infarction, stroke
时间窗: Five years from study start
Death: Death will be sub-classified by vascular or non-vascular primary cause. All deaths with unknown/uncertain cause will be categorized as vascular death. Myocardial Infarction(MI): Rehospitalization due to new non fatal MI or development of significant Q-wave. Stroke: Diagnosed as abrupt onset of focal neurological deficit persisting more than 24 hours.
次要结局
- Venous thromboembolism, Arterial embolism, Bleeding(Five years from study start)