A Randomised Prospective Study of an Invasive Strategy Versus Medical Therapy in Patients Over 80 Years With Non ST-Elevation Myocardial Infarction (NSTEMI) or Unstable Angina Pectoris (UAP)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 492
- 试验地点
- 1
- 主要终点
- Composite endpoints.
研究概览
简要总结
The rationale of the present clinical trial is to study whether an invasive strategy in clinical stable patients over 80 years with NSTEMI/UAP may improve rates of death, reinfarction, stroke, need of urgent revascularisation, myocardial function and quality of life. The invasive approach involves coronary angiography with immediate evaluation for three different treatment options; 1. Percutaneous coronary intervention (PCI), 2. Coronary artery bypass graft (CABG) or 3. medical treatment. Clinical practice shows that older patients are commonly treated less vigorously than younger patients and the present guidelines are based on a considerably younger population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 80 years.
- •Acute coronary syndrome (NSTEMI/UAP) with chest pain > 10 minutes, with or without ST-segment depression in ECG, and normal or elevated levels of troponin T or I. Elevated troponin levels are defined as values exceeding the 99 percentile of a normal population at the local laboratory at each participating site.
- •Clinical stable
排除标准
- •Age < 80 years.
- •ST-segment elevation in ECG (STEMI)
- •Clinical unstable with ongoing chest pain or other ischaemic symptoms/signs.
- •Cardiogenic shock.
- •Short life expectancy due to extra cardiac reason, ie. COPD, disseminated malignant disease, or other reason.
- •Anamnestic indications for significant mental disorder, including dementia.
- •Any condition which interferes with patients possibility to comply with protocol.
结局指标
主要结局
Composite endpoints.
时间窗: One year follow up.
Does an invasive strategy in clinical stable patients over 80 years with NSTEMI/UAP improve rates of death, reinfarction, stroke and need of urgent revascularisation?
次要结局
- Death of any cause(One year from randomization)
研究者
Oslo University Hospital
Bjørn Bendz MD PhD
Oslo University Hospital