NCT01836211终止不适用
High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain: a Randomized Controlled Study
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department
研究概览
简要总结
- The purpose of this study is to determine the efficacy and safety of an evaluation strategy based on utilization of high sensitivity cardiac troponin T (hscTnT), followed by coronary computed tomography angiography (CCTA) in patients with low-intermediate risk chest pain consistent with a possible acute coronary syndrome compared to a standard of care (SOC) strategy.
- Unicentric, randomized, controlled, open label clinical trial that will compare a fast strategy (hscTnT followed by CCTA) with a SOC strategy (serial ECG and cardiac biomarkers followed by stress/rest imaging study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chest pain consistent with possible acute coronary syndrome.
- •Age > 18 years.
- •Informed consent.
排除标准
- •Previous history of coronary artery disease.
- •Electrocardiogram diagnostic or suggestive of myocardial ischemia.
- •Condition other than coronary artery disease as cause of an imbalance between myocardial oxygen supply and/or demand (eg. anemia, fever, arrhythmias).
- •Chronic kidney disease (GFR <30 mL/min/1,73 m2).
- •Iodine contrast allergy.
- •Incapability to perform treadmill stress test.
- •Barthel activity of daily living scale index < 100.
结局指标
主要结局
All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department
时间窗: 1 month after index event
Composite end-point.
次要结局
- Heart Failure(1 month)
- All cause mortality(1 month)
- Myocardial infarction(1 month)
- Unstable angina(1 month)
- Hospital admission(1 month)
研究者
研究点 (2)
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