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临床试验/NCT04851418
NCT04851418Unknown不适用

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

St. Antonius Hospital2 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2020年9月1日最近更新:
适应症

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:

  1. To evaluate the interobserver agreement of the HEART-score performed by ambulance personnel compared to the HEART-score performed by emergency physicians.
  2. 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).
  3. 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.
  4. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

J.M. ten Berg

Prof. Dr. J.M. ten Berg

St. Antonius Hospital

研究点 (2)

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