Coronary Computed Tomographic Angiography in Emergency Department Chest Pain Patients at Intermediate Risk of Acute Coronary Syndrome
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Emergency Department Admission Time
研究概览
简要总结
The purpose of this study is to determine whether Coronary Computed Tomographic Angiography (CCTA) will increase patient safety by decreasing the rate of missed ACS and adverse events in patients who receive standard care plus CCTA versus standard care alone. Additional goals of the study are to determine whether CCTA can safely reduce the duration of ED visits and the number and duration of hospital admissions.
详细描述
Justification:
Acute coronary syndrome (ACS) is the clinical manifestation of acute myocardial ischemia induced by coronary artery disease (CAD). Although most patients presenting with chest pain to the Emergency Department (ED) can be stratified into "high risk" or "low risk" chest pain algorithms, patients at "intermediate risk" are more difficult to manage. This translates into lengthy waits in the ED and repetitive investigations while 5.3% of cases of ACS are still missed and too many patients are admitted to the CCU (false positive rate of 14%). CCTA is a novel, non-invasive method for evaluating coronary artery stenosis and occlusion.
The ability to accurately diagnose or exclude ACS in patients in a rapid, non-invasive fashion has been previously lacking. If CCTA is shown to be clinically useful in risk stratification of this patient population, there is great potential for increasing patient safety, reducing ED admission times and decreasing the number and duration of CCU admission.
Objectives:
ED admission and discharge times, CCU consult and decision times and duration of CCU admission, cardiac risk factors, vital signs, laboratory results, ED disposition plan, CCTA results, coronary calcium score, index hospitalization diagnosis, investigations, revascularization rates as well as 30-day diagnosis, death, adverse event rate and subsequent investigations.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(all of the following):
- •Anterior or lateral chest pain
- •19 years of age or older
- •Fixed address in British Columbia
- •Available for telephone follow-up
排除标准
- •(any of the following).
- •Low Risk for ACS (all of the following):
- •Age < 40 years with normal ECG (T wave flattening is the only acceptable abnormality)
- •No prior history of ischemic chest pain (defined as a past diagnosis of MI or angina, previously prescribed nitroglycerine or a clear history of effort related angina)
- •High Risk for ACS (any of the following):
- •Diagnosis consistent with ST elevation myocardial infarction
- •New ST depression ≥ 0.05 mV
- •Troponin > 0.1
- •Patients with Killip class III or IV heart failure.
- •Hemodynamic instability
- •Previous enrolment in this study.
- •Presence of terminal noncardiac illness.
- •History of angioplasty with stenting and/or grafts.
- •Presence of atrial fibrillation.
- •Contraindication to administration of iodinated contrast agent.
- •Contraindication to beta-blocker administration (eg, asthmatics) AND calcium channel blocker administration.
- •Glomerular filtration rate less than 60 mL/min.
- •Previous ECG-gated CT with calcium score >1000 Agatston Units.
- •Pregnancy.
- •Patients with communication difficulties.
- •Patients who have a clear alternative diagnosis other than ischemic chest pain (e.g. traumatic chest pain or pneumonia).
研究组 & 干预措施
intervention
Receives CCTA
干预措施: Coronary Computed Tomographic Angiography (Procedure)
Control
结局指标
主要结局
Emergency Department Admission Time
时间窗: During initial presentation to hospital
次要结局
- CCU consult time(During initial presentation to hospital)
- CCU decision time(During initial presentation to hospital)
- Duration of CCU admission(During initial presentation to hospital)
- Adverse event rate(30 days post ED visit)
- All-cause mortality(30 days post-ED visit)