Better Evaluation of Acute Chest Pain With Computed Tomography Angiography (BEACON)
Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Rotterdam、荷兰
- Erasmus MC
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Acute chest pain or equivalent
- Patients older than 30 years
- Males < 75 years and Females < 80 years
Exclusion Criteria:
- STEMI
- Troponin > 0.1
- History of known myocardial infarction, PCI or CABG
- Pregnancy
- Contrast allergy
- Renal disfunction
- No informed consent possible
- No follow-up possible
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Cardiac CT
Triage based on cardiac CT results.
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Calcium scan and CT coronary angiography
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无干预：Standard Care
Standard diagnostic management according to the European guidelines.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Successful discharge rate
大体时间：30 days
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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.
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30 days
|
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Diagnostic yield of invasive angiography
大体时间：30 days
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Number of patients identified with severe coronary artery disease identified by invasive angiography requiring revascularisation according to the international guidelines.
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30 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Successful discharge rate for all adverse events
大体时间：30 days
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The proportion of patients discharged home without any adverse events during the following 30 days.
Adverse events are cardiovascular death, non-fatal myocardial infarction, unstable angina, coronary revascularization, repeat hospital visits for chest pain.
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30 days
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Major adverse events
大体时间：6 months
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Composite endpoint of major adverse cardiac events at 6 months: cardiovascular death, non-fatal myocardial infarction, unstable angina, coronary revascularisation and repeat hospital visits for chest pain.
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6 months
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Acute coronary syndrome
大体时间：Index hospital visit
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Diagnosis of acute coronary syndrome, according to international guidelines, at time of discharge.
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Index hospital visit
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Missed myocardial infarctions
大体时间：2 days
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Missed myocardial infarctions, at 2-day follow-up, in patients discharged from the emergency department.
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2 days
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Duration of hospital stay
大体时间：Index hospital visit
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Duration of hospital stay
|
Index hospital visit
|
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Direct medical cost
大体时间：30 days
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Direct medical costs until 30th day after ED visit.
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30 days
|
|
Radiation exposure
大体时间：6 months
|
Cumulative medical radiation exposure at 6 months.
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6 months
|
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Renal function
大体时间：2 days
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Change in renal function after 2 days.
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2 days
|
合作者和调查者
调查人员
- 首席研究员：Koen Nieman, MD, PhD、Erasmus MC
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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