Improved Management of Acute Chest Pain in Emergency Primary Care. The OUT-POC Study (One-hoUr Troponin Using a High-sensitivity Point-Of-Care Assay in Emergency Primary Care)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,500
- 试验地点
- 14
- 主要终点
- Total number of acute myocardial infarctions at the index episode
研究概览
简要总结
Acute chest pain is a prevalent medical emergency in primary emergency care settings. Triage of chest pain prior to hospital admission presents significant challenges due to the absence of sufficiently sensitive diagnostic tools. Clinical signs, symptoms, risk assessment scores, or a normal electrocardiogram (ECG) can reliably exclude acute myocardial infarction (MI). This diagnostic uncertainty has resulted in chest pain being the second most common cause for acute hospital referrals from Norwegian emergency primary care, even though chest pain is frequently non-cardiac in origin.
In acute MI events, cardiac troponins are released into the bloodstream from the damaged myocardium, where low values are used to exclude MI. Until recently, such testing has necessitated using high-sensitivity cardiac troponin (hs-cTn) assays, which have been limited to hospital laboratories. However, recent technological advancements in point-of-care (POC) testing allow access to whole-blood assays that meet high-sensitivity criteria.
In this upcoming project, the investigators will evaluate the implementation of a whole-blood POC assay (QuidelOrtho TriageTrue hs-cTnI) across six Norwegian emergency primary care clinics. The study plans to enrol 2,500 patients over a period of 1.5 years. The clinical performance of the novel strategy will be investigated, as well as its impact on healthcare utilization and hospital referrals compared to standard care. Additionally, the investigators will assess the prevalence of persistent chest pain and its effects on quality of life, alongside psychological stress and anxiety, through validated questionnaires.
This project aims to offer better and more comprehensive management of the large group of emergency primary care patients with acute chest pain, contributing to reduced hospital referrals, improved quality of life, and more sustainable use of healthcare services.
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
- •Patients (18+ years) with non-traumatic acute chest pain presenting in emergency primary care
- •Troponin testing requested by the treating physician
排除标准
- •Acute STEMI (direct hospital referral required)
- •Haemodynamically unstable (direct hospital referral required)
- •Not able to provide written, informed consent (i.e., due to time restraints, language barriers, impaired cognitive function, or other reasons)
研究组 & 干预措施
TriageTrue hs-cTnI 0/1-hour algorithm
Study participants will have a venous blood sample done for hs-cTnI testing using the QuidelOrthos TriageTrue whole-blood POC assay. The treating physician will evaluate the results using an assay-specific 0/1-hour algorithm (developed by Boeddinghaus et al., 2020).
干预措施: QuidelOrthos TriageTrue hs-cTnI whole-blood assay (Diagnostic Test)
结局指标
主要结局
Total number of acute myocardial infarctions at the index episode
时间窗: From baseline to 30 days
Proportion of acute myocardial infarction at baseline, to assess the predictive performance of the TriageTrue 0/1-hour algorithm (incl. safety and accuracy) at index
PROM: Health-related quality of life
时间窗: At baseline and repeated after 90 days
Differences in health-related quality of life among chest pain participants will be assessed through self-reported EQ-5D questionnaire with five levels (EQ-5D-5L) incl. the EQ-5D visual analogue scale (EQ VAS).
次要结局
- Healthcare costs(From baseline to 1 year)
- Efficiency(Baseline)
- Total number of hospital referrals at index(Baseline)
- Total length of stay(Baseline to 24 hours)
- PROM: Depression(At baseline and repeated after 90 days)
- Incremental cost-effectiveness ratio(From baseline to 1 year)
- Composite of acute MI and all-cause death(From baseline to 1 year)
- PROM: Burden of chest pain(At baseline and repeated after 90 days)
- Societal costs(From baseline to 1 year)
- PROM: Cardiac Anxiety(At baseline and repeated after 90 days)
- PROM: Insomnia(At baseline and repeated after 90 days)
- Healthcare utilization(From baseline to 1 year)
研究者
Tonje R. Johannessen
Principal Investigator
University of Oslo