Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,153
- 试验地点
- 12
- 主要终点
- Rate of major cardiac events
研究概览
简要总结
Acute coronary syndrome (ACS) is a major public health problem and its diagnosis remains a challenge for the emergency physician. The European Society of Cardiology recommends a troponin dosage and renew it if necessary during any suspicion of ACS. However, the criteria leading to initiate a diagnostic procedure during chest pain are imprecise. The fear is, on the one hand, to miss a potentially vital diagnosis and, on the other hand, to expose a large number of patients to unnecessary examinations.
The CARE rule (also known as HEAR score) seems to streamline this first step. It assigns a value of 0 to 2 using 4 items: Characteristic of pain, Age, Risk factors and Electrocardiogram (ECG). The search for an ACS is not justified if the sum of the points is <2 (negative rule) and, inversely, a troponin determination must be carried out if the sum is > 1 (positive rule).
The aim of the study is to demonstrate the safety and interest of the CARE rule associated with the HEART score to streamline ACS's diagnostic approach to thoracic pain in emergencies departments.
详细描述
Data collected in this study are not anticipated to be published in a data repository. However, data will be shared per requested need to researchers, upon presentation of a structured protocol, when approved by the competent ethic committee and approved by the steering committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to an Emergency Department participating in the study
- •Non-traumatic chest pain
- •Age greater than or equal to 18 years
- •Patient's consent (oral for France, written for Belgium)
排除标准
- •30 days follow-up not possible
- •ST-segment Elevation Myocardial Infarction (STEMI) on admittance ECG
- •Chest pain formally reported to a diagnosis other than an ACS before inclusion (e.g., pneumothorax, pleurisy, etc.)
- •Troponin assay performed prior to inclusion (less than 24 hours old)
- •Patient referred by another care structure (excluding primary medicine)
- •Patient already included in study still in follow-up period
- •Pregnant, breastfeeding or parturient patient,
- •Patient deprived of liberty by judicial or administrative decision,
- •Patient undergoing psychiatric care under duress,
- •Patient subject to a legal protection measure,
- •Patient unable to give free and informed consent.
结局指标
主要结局
Rate of major cardiac events
时间窗: 30 days
Myocardial infarction, percutaneous or surgical coronary reperfusion, certain or potential cardiac death, or surviving cardiac arrest
次要结局
- Rate of major cardiac events for the intention to treat study population(30 days)
- Number of troponin assays in the intention to treat population(2 days)
- Time spent in the emergency department in the intention to treat population(2 days)