A Multicentre Randomized Controlled Trial to Improve the accUracy of Referrals to the emerGency departmEnt of patieNts With chesT Pain by Using the Modified HEART Score in Emergency Medical Transport (URGENT 2.0)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 852
- 试验地点
- 4
- 主要终点
- The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED (percentage, %)
研究概览
简要总结
This is a multicenter, prospective, investigator-initiated, randomized controlled trial aiming to reduce the percentage of non-cardiac chest pain (NCCP) patients admitted to the cardiac emergency department (ED) by performing the modified HEART score by emergency medical transport (EMT) personnel.
详细描述
Patients with acute coronary syndrome (ACS) should be referred to the hospital promptly. However, referring all patients with chest pain is not feasible, as recent studies showed that up to 80% of the patients with acute chest pain do not have ACS.
Bedside point-of-care (POC) high sensitive troponin testing (in fingerprick blood/capillary blood) and the modified HEART score have become available and might play a substantial role in the triage and diagnosis of chest pain patients in a pre-hospital setting by general practitioners (GPs) and EMT personnel in the future. We hypothesize that patients with chest pain can be referred more accurately by using the modified HEART score.
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 (Care Provider, Investigator)
盲法说明
EMT personnel will be blinded for the randomisation sequence.
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 ≥ 18 years.
- •Chest pain or other complaints suspect of ACS for at least 2 hours where the GP or emergency medical personnel are in need of further diagnostics or risk stratification to come to a decision of referral.
- •Patients, who have been informed of the nature of the study, agree to its provisions and have provided written informed consent.
排除标准
- •Electrocardiographic ST-segment elevation/High suspicion of STE-ACS.
- •Suspicion of an acute non-coronary diagnosis e.g. pulmonary embolism, thoracic aortic dissection or other life-threatening disease.
- •Patients presenting cardiogenic shock, defined as: systolic blood pressure <90mmHg and heart rate >100 and peripheral oxygen saturation <90% (without oxygen administration)
- •Patients presenting with sudden onset heart rhythm disorders and second or third degree atrioventricular block.
- •Patients with confirmed ACS, PCI or CABG <30 days prior to inclusion.
- •Impaired consciousness defined as an EMV <
- •Severe shortness of breath.
- •Patients with known end-stage renal disease (dialysis and/or MDRD < 30 ml/min).
- •Patients with known cognitive impairment.
- •Communication issues with patient/language barrier.
- •Patients already participating in an interventional cardiology or cardiovascular trial.
结局指标
主要结局
The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED (percentage, %)
时间窗: 30 days
Evaluation of the percentage of NCCP patients admitted to the cardiac ED by performing the modified HEART score in comparison to our control group (regular triage and care). We aim to detect a reduction of minimal 10% in unnecessarily referred chest pain patients (NCCP patients) but expect an even higher percentage. A lower percentage of NCCP patients indicates improval of the triage of chest pain patients.
The incidence of MACE (percentage, %)
时间窗: 30 days, 6 months and 1 year
The mortality and major adverse cardiovascular events (MACE) i.e. acute myocardial infarction, non-elective percutaneous coronary intervention, coronary artery bypass grafting or all cause death within 30 days, 6 months and 1 year after initial presentation in the intervention group versus control group. We aim that the proportion of MACE in the intervention group (modified HEART score) is non-inferior to the control group (regular care and triage). Preliminary results of the second phase of FAMOUS Triage trial showed 15.7% (13.1-18.6) MACE rate.We used the expected incidence of 15.7% as the point estimate (meaning no difference between control and intervention). A higher MACE rate (%) in the intervention group suggests a worst outcome.
次要结局
- Overview of the actual diagnosis of patients with a low modified HEART score (0-3).(30 days)
- Time analysis.(30 days)
- Clinical accuracy POC hs cTnI.(30 days)
- The incidence of MACE in subgroups (percentage, %)(30 days, 6 months and 1 year)
- The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED in subgroups (percentage, %)(30 days, 6 months and 1 year)
- Cost-effectiveness analysis(30 days, 6 months and 1 year)
- Assessment of the diagnostic value of the modified HEART score.(30 days, 6 months and 1 year)
- Overview of the actual diagnosis of patients with moderate-high modified HEART score (>3).(30 days)
研究者
Braim Rahel
Principal investigator
VieCuri Medical Centre