Randomized Comparison Between Invasive and Conservative Strategies in Patients With Non-ST-segment Elevation Acute Coronary Syndrome and Comorbidities
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 6
- 主要终点
- All cause mortality, reinfarction or reasmission by cardiac cause
研究概览
简要总结
The guidelines of clinical practice, based on the randomized studies, recommend an invasive strategy in non-ST elevation acute coronary syndrome (NSTEACS). However, patients with comorbidities are excluded from the randomized studies and the observational registries showthat patients with comoribidities undergo fewer cardiac catheterizations. The aim is to investigate the benefit of the invasive strategy in patients with NSTEACS and comorbidities.
Patients hospitalized with NSTEACS, older than 70 years and with significant comorbidities, will be included. The latter will be defined as at least 2 of the following: peripheral artery disease, cerebral vascular disease, dementia, chronic pulmonary disease, chronic renal failure and anemia. The included patients will be randomized to an invasive (routine coronary angiogram) or conservative (coronary angiogram only if recurrent or inducible ischemia) strategy. All patients will receive medical treatment according to current recommendations.
The main outcome will be death, reinfarction or readmissions by heart cause at one-year follow-up. The hypothesis is that an invasive strategy will improve prognosis in patients with NSTEACS and comorbidities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age =>70 years old
- •Angina chest pain
- •Troponin elevation
- •At least 2 of the following comorbidities: A) Documented peripheral artery disease. B)Renal filaure (GFR <45 ml/min/m2). C) Neurological disease with permanent deficit. D) Dementia (Pfeiffer test). E) Chronic pulmonary disease (Gold>2 or ambulatory oxigen therapy). Anemia (Hb =<11 g/dl)
排除标准
- •Dynamic ST changes (=>1 mm) in the initial ECG
- •Prior known non-revascularizable coronay disease
- •Concomitant heart disease different to coronary disease
- •Life expentancy < 1 year
研究组 & 干预措施
Conservative
Coronary angiogram only if recurrent ischemia or peristent heart failure or inducible ischemia in predischarge stress test if perfomed
Invasive
Routine coronary angiogram
干预措施: Coronary angiogram (Procedure)
结局指标
主要结局
All cause mortality, reinfarction or reasmission by cardiac cause
时间窗: 1 year
次要结局
- Days alive out of the hospital(1 year)
- Renal failure(In-hospital (average= 1 week))
- Bleeding(In-hospital (average= 1 week))
研究者
Juan Sanchis
Full Professor of Medicine
University of Valencia