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临床试验/NCT03913767
NCT03913767已完成不适用

Combination of ECG and Cardiovascular Risk Factors Could Increase Diagnostic Performance Of Chest Pain Triage at ED

Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年11月1日最近更新:
适应症

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
Comparison of the diagnostic performance of the two triage systems.

研究概览

简要总结

CECIDOC is a prospective, monocentric and observational study comparing the diagnostic performance of ECG-base triage to a combination of ECG and cardiovascular risk factors for chest pain triage at ED.

详细描述

Background

Acute chest pain triage in the Emergency Department (ED) may prove challenging, since similar symptoms can reveal both mild or life-threatening disorders, and the clinical presentation itself is known not to be reliable for evaluating the risk of acute coronary syndrome (ACS) .

The first priority in patients with suspected ACS is to identify those with ST-elevation myocardial infarction (STEMI), since these patients require urgent reperfusion therapy. Both European and American cardiology guidelines recommend implementation of a 12-lead electrocardiogram (ECG) within 10 min of arrival in the ED.

In contrast, in the absence of electrocardiographic changes consistent with ischemia, the ACS rate is low (1-8% depending on the number of risk factors) , and ACS are associated with lower in-hospital mortality.

Emergency Department (ED) triage systems for acute chest pain are either based on clinical features or on a 12-lead ECG. A recent study showed the systems having a similar diagnostic performance but different characteristics since clinical-based triage had a higher sensitivity and ECG-based triage had a higher specificity. The lack of sensitivity of ECG based triage was explained by the fact that patients with a normal or non-ischemic ECG were assigned to a low-acuity triage score, defined as inadequate (false negative) for ACS patients. Conversely, the lack of specificity of clinical based triage was due to a large number of patients with benign pathology assigned to a high-acuity triage score to perform a 12-lead ECG within the 10 minutes after the first medical contact as required.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • non traumatic chest pain at ED

排除标准

  • under 18y

结局指标

主要结局

Comparison of the diagnostic performance of the two triage systems.

时间窗: 2 years

Diagnostic performance of ECG and combination of ECG and cardiovascular risk factor to triage chest pain patient at ED will be compared by calculating the Area Under the ROC Curves of the two triage systems.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mélanie DECHAMPS

Consultant

Université Catholique de Louvain

研究点 (1)

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