Pre-hOspital Evaluation of Chest Pain Patients With sUspected Non ST-segment eLevation myocARdial Infarction Using the HEART-score With a Troponin Point-of-care Test
试验速览
- 阶段
- 不适用
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Heart score agreement
研究概览
简要总结
Overcrowding in the emergency department is an increasing problem in hospitals worldwide. Point-of-care Troponin (POC cTn) testing combined with a well investigated risk stratification tool (HEART-score) used in the ambulance may contribute to more rapidly diagnostics of ruling in or ruling out myocardial infarctions (MI) and subsequently reduce unnecessary hospital admissions, total admission time and costs. However, the applicability of the POC cTn and the HEART-score in the pre-hospital setting remains unclear. This study will evaluate this applicability.
详细描述
Co-primary Objectives:
- To evaluate the interobserver agreement of the HEART-score performed by ambulance personnel compared to the HEART-score performed by emergency physicians.
- To evaluate the diagnostic performance of a strategy based on a pre-hospital HEART-score (with POC cTn testing) or combined with an adjuvant single hs-cTn test at the emergency department to rule-in or rule-out acute coronary syndrome (ACS).
- To evaluate the diagnostic performance of (serial) POC cTn testing or combined with hs-cTn testing compared to (serial) hs-cTn testing to rule-in or rule-out MI.
- To investigate the feasibility of using the pre-hospital HEART-score and POC cTn in the 0/1 hour algorithm to rule-out ACS.
Secondary Objectives: 5. To evaluate the occurrence of major adverse cardiac events (MACE) in all included patients with a follow up time of 30 days from first medical contact. 6. To evaluate the patient reported outcome measures (PROMs) in all chest pain patients transported to the hospital at baseline and at 30 days 7. To perform a cost-analysis of an early diagnostic strategy using the pre-hospital HEART-score
Study design: A prospective, observational, single multicentre study Study population: Total number of patients needed for analysis: n=650 Inclusion criteria: - All out-of-hospital chest pain patients visited by an ambulance
- Transportation to a hospital with working diagnosis NSTE-ACS
- Age ≥ 18 years Exclusion criteria: - Comatose state, hemodynamic instability or shock
- Electrocardiographic ST-segment elevation in the pre-hospital setting treated as STEMI
- No pre-hospital 12-lead electrocardiogram performed or available
- An obvious non-cardiac cause for the chest pain (trauma, etc.)
- Suspicion of aortic dissection or pulmonary embolism
- Cognitive impairment
- Pregnancy
- Suspicion of COVID-19 by ambulance
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
- 否
入选标准
- •All out-of-hospital chest pain patients visited by an ambulance
- •Transportation to a hospital with working diagnosis NSTE-ACS
- •Age ≥ 18 years
排除标准
- •Comatose state, hemodynamic instability or shock
- •Electrocardiographic ST-segment elevation in the pre-hospital setting
- •No pre-hospital 12-lead electrocardiogram performed or available
- •An obvious non-cardiac cause for the chest pain (trauma, etc.)
- •Suspicion of aortic dissection or pulmonary embolism
- •Cognitive impairment
- •Pregnancy
结局指标
主要结局
Heart score agreement
时间窗: 1 year
HEART-score agreement (interobserver variability between pre-hospital and in-hospital HEART-score assessment): the calculated heart score by the ambulance will be subtracted from the calculated score of the emergency department. The minimum value could be -10 and the maximum value could be +10. A positive score means that the ambulance estimates the patient to be sicker or at higher risk. A negative value means that the ED estimates the patient to be sicker/at higher risk for developing major adverse cardiac events.
Number of participants with final diagnosis of NSTE-ACS
时间窗: 1 year
final diagnosis of NSTE-ACS (non-ST elevation myocardial infarction and unstable angina pectoris) at discharge
Number of participants with final diagnosis of myocardial infarction at discharge
时间窗: 1 year
Myocardial infarction at discharge
次要结局
- Number of participants with a composite endpoint(30 days)
- Patient reported outcome measure: Seattle Angina questionnaire (SAQ)(30 days)
- Patient reported outcome measure: Patient Health Questionnaire 4(30 days)
研究者
J.M. ten Berg
Prof. Dr. J.M. ten Berg
St. Antonius Hospital
