Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Successful discharge rate
研究概览
简要总结
The purpose of this study is to determine whether cardiac CT can improve triage of acute chest pain patients in the emergency department.
详细描述
Myocardial infarction remains one of the most important causes of death and disability. Therefore it is important that individuals with acute chest pain are accurately assessed without delaying appropriate treatment. Acute coronary syndrome is only one cause for sudden chest pain, which is a very common complaint in the ER. Other life threatening causes such as pulmonary embolism and aortic dissection may also be the cause, although most chest discomfort has a benign reason (musculoskeletal, hyperventilation, oesophageal reflux, etc).
The current work-up of suspected acute coronary syndrome, based on presentation, symptoms, ECG and biomarkers, is not efficient and results in unnecessary diagnostics and hospital admissions, as well as errors or delayed diagnoses, in a substantial number of patients. Computed tomography angiography (CTA) images atherosclerosis, coronary obstruction as well as myocardial hypoperfusion. We hypothesize that early use of CTA is of incremental value and allows for accurate and immediate triage of patients with acute chest pain.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute chest pain or equivalent
- •Patients older than 30 years
- •Males < 75 years and Females < 80 years
排除标准
- •Troponin > 0.1
- •History of known myocardial infarction, PCI or CABG
- •Pregnancy
- •Contrast allergy
- •Renal disfunction
- •No informed consent possible
- •No follow-up possible
结局指标
主要结局
Successful discharge rate
时间窗: 30 days
The proportion of patients discharged home without major adverse events during the following 30 days. Major adverse events are cardiovascular death or non-fatal myocardial infarction.
Diagnostic yield of invasive angiography
时间窗: 30 days
Number of patients identified with severe coronary artery disease identified by invasive angiography requiring revascularisation according to the international guidelines.
次要结局
- Successful discharge rate for all adverse events(30 days)
- Major adverse events(6 months)
- Duration of hospital stay(Index hospital visit)
- Direct medical cost(30 days)
- Missed myocardial infarctions(2 days)
- Radiation exposure(6 months)
- Acute coronary syndrome(Index hospital visit)
- Renal function(2 days)
研究者
Koen Nieman
Associate professor
Erasmus Medical Center