Randomized Controlled Trial of Multi-Slice Coronary Computed Tomography for Evaluation of Acute Chest Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Length of stay
研究概览
简要总结
The purpose of this study is to determine whether coronary artery computed tomography scanning is a more rapid, less expensive and safe alternative to standard diagnostic evaluation of patients with acute chest pain in the emergency room.
详细描述
Over 6 million patients per year visit hospital emergency departments for evaluation of chest pain, with diagnostic costs estimated to be in excess of $10 billion. Standard diagnostic evaluation often includes 8-12 hours of serial laboratory tests followed by stress imaging studies requiring an additional 4-8 hours.
Multi-slice coronary artery computed tomography scanning (MSCT) has been shown to be a highly accurate diagnostic method in comparison to invasive angiography. Because of its speed and high negative predictive value, MSCT could rapidly screen patients for the presence of coronary disease, which may expedite their care.
This study compares the length of stay and cost of care in emergency chest pain patients randomly assigned to initial evaluation by MSCT compared to patients randomly assigned to a standard diagnostic evaluation including single photon emission computed tomography scanning. The study follows these patients to detect major adverse cardiac events including unstable angina, acute myocardial infarction or death over a 90-day period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chest pain or angina equivalent symptoms.
- •Age ≥ 25 years.
- •Low risk of infarction and/or complications by Goldman/Reilly criteria.
排除标准
- •Known coronary artery disease.
- •Electrocardiogram diagnostic of acute cardiac ischemia and/or infarction.
- •Elevated serum biomarkers including creatine kinase (CK) MB, myoglobin, and/or cardiac troponin I on initial testing.
- •Contraindication to iodinated contrast and/or beta blocking drugs.
- •Atrial fibrillation or markedly irregular rhythm.
- •Pregnancy.
- •Renal insufficiency, creatinine > 1.5 mg/dL.
- •Iodinated contrast within prior 48 hours.
结局指标
主要结局
Length of stay
Cost of care
次要结局
- Unstable angina within 90-days
- Acute myocardial infarction within 90-days
- Cardiac death within 90-days