Acute Rule Out of Non ST-segment Elevation Acute Coronary Syndrome in the (Pre)Hospital Setting by HEART Score Assessment and a Single Point-of-care Troponin
试验速览
- 阶段
- 不适用
- 入组人数
- 866
- 试验地点
- 1
- 主要终点
- Costs from a healthcare perspective (all costs related to healthcare consumption in-hospital, all outpatient visits including diagnostic tests and general practitioner consultations)
研究概览
简要总结
Patients with chest pain suspected for non ST-segment elevation acute coronary syndrome (NSTE-ACS) are routinely transferred to the emergency department (ED). A point-of-care (POC) troponin measurement might enable ambulance paramedics to identify low-risk patients in whom ED evaluation is not necessary. The ARTICA trial aims to assess the healthcare cost reduction and safety of a pre-hospital rule-out strategy using a single POC troponin measurement.
详细描述
Patients with chest pain suspected of a NSTE-ACS are screened by ambulance paramedics. The HEAR score (HEART score without the Troponin component) is assessed and patients with a HEAR score of ≤3 are included. The patients are randomised to 1) pre-hospital rule-out with POC troponin measurement (intervention group) and 2) direct transfer to the ED (standard care group). Primary outcome is healthcare costs after 30 days.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The clinical events are blindly adjudicated by an independent Clinical Events Committee
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
- •Age at least 18 years; male ánd female
- •All out-of-hospital patients with chest pain or symptoms suggestive of ACS initially visited by an ambulance with an indication for transfer to a hospital to evaluate and rule out ACS
- •Symptom duration for at least two hours
- •Modified HEAR(T) score less or equal than 3
- •A point of care troponin below the upper reference limit (for patients stratified to pre-hospital management by the general practitioner)
- •The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
排除标准
- •Electrocardiographic ST-segment elevation
- •Patients presenting an obvious non-cardiac cause for the chest complaints who need evaluation at an emergency department, e.g. trauma, pneumothorax, sepsis, etc.
- •Patients in comatose state, defined as an Glascgow coma scale (GCS) <8
- •Patients with known cognitive impairment
- •Pregnancy or intention to become pregnant during the course of the study
- •Patients presenting cardiogenic shock, defined as: systolic blood pressure <90 mmHg and heart rate >100 beats per minute and peripheral oxygen saturation <90% (without oxygen administration)
- •Patients presenting with syncope
- •Patients presenting with signs of heart failure
- •Patients presenting with heart rhythm disorders and second or third degree atrioventricular block
- •Patients with known end-stage renal disease (dialysis and/or glomular filtration rate (GFR) < 30 ml/min)
- •Patients without a pre-hospital 12-lead ECG performed or available
- •Patients suspicious of aortic dissection or pulmonary embolism
- •Patients with confirmed acute myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting <30 days prior to inclusion
- •Communication issues with patient/language barrier
- •Decision of a present general practitioner to evaluate the patient at the emergency department (ED)
- •Decision of the consultant cardiologist to evaluate patient at the ER irrespective of HEART score
- •Any significant medical or mental condition, which in the Investigators opinion may interfere with the patients optimal participation in the study
研究组 & 干预措施
Pre-hospital rule-out strategy
Patients undergo a point-of-care troponin T measurement. If troponin is low, an acute coronary syndrome is considered ruled-out and the care for the patient is transferred to the general practitioner. If troponin is elevated, the patient is immediately transported to the emergency department.
干预措施: Pre-hospital rule-out strategy (Diagnostic Test)
Emergency department rule-out strategy
According to standard care, the patients are immediately transported to the emergency department.
结局指标
主要结局
Costs from a healthcare perspective (all costs related to healthcare consumption in-hospital, all outpatient visits including diagnostic tests and general practitioner consultations)
时间窗: 30 days
Healthcare costs consist of all costs related to healthcare consumption
次要结局
- Safety: all cause death, acute coronary syndrome, unplanned revascularisation(30 days)
- Costs from a societal perspective (all health effects and changes in resource use caused by an intervention)(30 days)
- Safety (all cause death, acute coronary syndrome, unplanned revascularisation)(12 months)
- Safety (all cause death, acute coronary syndrome, unplanned revascularisation)(6 months)
研究者
Cyril Camaro
Principal Investigator
Radboud University Medical Center