Safety and Efficacy of Implementing Low-Dose Coronary Computed Tomographic Angiography for Early Triage of Acute Chest Pain in Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 681
- 试验地点
- 6
- 主要终点
- Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings
研究概览
简要总结
This study is to see whether the low-dose coronary computed tomographic angiography (CCTA) protocol is as safe and efficacious as conventional-dose protocol in early triage of acute chest pain.
详细描述
Currently, CCTA is a valuable tool for early triage of low to intermediate risk acute chest pain patients in emergency department. However, it has been criticized for causing unnecessary radiation exposure in the population where its majority has no coronary lesion. A low-dose CCTA protocol comprised with 1) dedicated cardiac imaging protocol (rather than triple rule-out protocol), 2) prospective gating and 3) without additional imaging for calcium scoring will be used to implement the low-dose imaging. We hypothesized that the low-dose CCTA protocol will be as safe and efficacious as conventional dose protocol while decreasing the amount of radiation exposure significantly.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients visiting emergency department for A) acute onset (<12hr) chest pain or equivalent symptoms B) aged between 25-55, C) that requires to rule out acute coronary syndrome.
排除标准
- •Known coronary artery disease and/or any related intervention (STENT, CABG)
- •Elevated cardiac biomarkers (CK-MB, Troponin I)
- •Ischemic ECG changes
- •Documented evidence of low LV systolic function (ejection fraction ≤ 45%)
- •TIMI risk >4
- •Unstable vital sign (e.g. hypoxemia, shock)
- •Patients with contraindication to iodinated contrast and/or beta blockers including renal failure or reactive airway diseases such as COPD or asthma
- •Atrial fibrillation on initial ECGs
- •Active renal disease, serum creatinine ≥1.5 mg/dl
- •Negative coronary angiography or CCTA within 6 months
- •Modified Wells criteria >4 or D-dimer > 0.5ug/mL
- •Suspicious of aortic dissection or D-dimer > 0.5ug/mL
结局指标
主要结局
Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings
时间窗: Within one month after discharge from emergency department
次要结局
- Total radiation dose exposed by index CT imaging and additional tests including SPECT and invasive angiography(During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge)
- Total length of ED and hospital stay(Time spent for index ED visit, which will be an average of 24 hours and total hospital stay until discharge, which will be an average of 7 days.)
- Direct comparison of frequency and overall cost of additional tests such as echocardiography, treadmill test, myocardial SPECT and coronary angiography(During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge)
- Direct comparison of accuracy (sensitivity, specificity, PPV, NPV) for between low-dose and conventional cardiac CT(One month after discharge from emergency department)