Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST+ ACS in the Management of Pre-hospital and In-hospital Non-traumatic Chest Pain in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 4
- 主要终点
- Demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old (sensitivity/specificity)
研究概览
简要总结
The aim of this study is to demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old.
详细描述
Chest pain accounts for about 10% of emergency service visits, which represents between 6 and 8 million visits per year in the United States and 15 million in Europe. Depending on the series, coronary etiology is found in 10 to 50% of cases.
Two types of coronary syndrome are distinguished according to the existence of a pathological change in the electrocardiogram.
ST+ acute coronary syndrome is a diagnosis based on the association of chest pain associated with an electrocardiogram change in the form of ST-segment elevation in a systemic territory corresponding to the complete obstruction of an artery of the coronary network.
Non-ST+ coronary syndrome is more difficult to diagnose, as the ECG is not pathological or cannot be interpreted due to the presence of conduction disorders. The diagnosis is currently based on the pathological increase of a specific myocardial biomarker in the blood: troponin.
If the pain is recent (less than six hours) the troponin measured on arrival may be falsely negative, and therefore requires a second measurement 3 hours after the first one (this is the troponin cycle). This second test therefore leads to a longer stay for patients requiring it and contributes to the saturation of the emergency service.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient ≥18 years old
- •Presenting at the Pontoise emergency department by their own means / ambulance or patients taken care of by the SMUR and referred to the NOVO hospital - Pontoise site
- •Chest pain less than 6 hours old
- •Chest pain suggestive of ACS (compressive, intense pain, radiating into the arm and neck, mid-thoracic, left thoracic or epigastric location)
- •Non-contributory ECG (no ST elevation, presence of bundle branch block)
- •Informed and having expressed no objection
- •Beneficiary of a social security system (or entitled person)
- •Non -Inclusion Criteria:
- •Sus ST-segment shift on ECG (ACS ST+)
- •Intermittent pain/unclear onset time
- •Pregnant woman
- •Pain in the context of trauma
- •Patient under guardianship
- •Patient does not speak or understand French
排除标准
- •Non-ultrasensitive troponin measurement positive during the 1st SMUR sampling (> 0.08 ng.dL)
- •Patient not referred to the NOVO hospital - Pontoise site by the SMUR
结局指标
主要结局
Demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old (sensitivity/specificity)
时间窗: At the end of the study, an average of 8 month
Comparison of copeptin and troponin assays in the final diagnosis of non-ST+ ACS based on emergency medical records by calculation the sensitivity/specificity of the troponin - copeptin pair.
Demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old (negative predictive value)
时间窗: At the end of the study, an average of 8 month
Comparison of copeptin and troponin assays in the final diagnosis of non-ST+ ACS based on emergency medical records by calculation of the negative predictive value of the troponin - copeptin pair.
次要结局
- Evaluation of the patient's length of stay(At the end of the Study, an average of 8 month)
- Evaluation of the diagnostic performance (sensitivity/specificity) of the troponin/ copeptin association according to cardiovascular risk factors (age, smoking, hypertension, history of cardiac ischemia, overweight, heredity)(At the end of the study, an average of 8 month)
- Evaluation of pain management in emergency service(At the end of the study, an average of 8 month)
- Evaluation of the diagnostic performance (negative predictive value) of the troponin/ copeptin association according to cardiovascular risk factors (age, smoking, hypertension, history of cardiac ischemia, overweight, heredity)(At the end of the study, an average of 8 month)
- Evaluation of the diagnostic performance of the troponin/ copeptin combination according to the time from onset of pain(At the end of the study, an average of 8 month)