Primary Care Decision Rule for Chest Pain Using the Marburg Heart Score and Hs-troponin I Point of Care Test to Rule Out Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 946
- 试验地点
- 2
- 主要终点
- Hospital referral rate for acute chest pain
研究概览
简要总结
The goal of this clustered, diagnostic randomized controlled trial is to study a clinical decision rule including a high-sensitive troponin I point of care test in patients with chest pain in primary care.
The main questions it aims to answer are:
- Can unnecessary referrals to secondary care be reduced by the use of a clinical deci-sion rule in patients with new onset, non-traumatic chest pain in primary care? Compared to current daily practice.
- What is the accuracy (sensitivity, negative prediction value) of the clinical decision rule for excluding ACS and MACE at 6 weeks and 6 months?
详细描述
This clustered, diagnostic randomized controlled trial will included patients with acute chest pain consulting their general practitioner. Practices in the intervention group will use a clinical decision rule consisting of the Marburg Heart Score and a high-sensitive troponin I point of care test to exclude acute coronary syndrome (ACS) and decide upon referral. Practices in the control group will apply usual care following local guidelines.
An independent endpoint committee consisting of a cardiologist and general practitioner will adjudicate the final diagnosis. Primary endpoints are ACS and Major Adverse Cardiac Events. A delayed reference standard of 6 months will be used.
For high sensitive troponin I measurement, the Siemens Atellica VTLi immunoassay analyser is used.
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
- 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
- •≥18 years of age
- •Acute chest pain
- •Seen by general practitioner
排除标准
- •<1 hour since onset of symptoms
- •Inability to speak or understand Dutch
- •Hemodynamic instability
研究组 & 干预措施
Clinical decision rule
Patients in whom the clinical decision rule is used to exclude acute coronary syndrome
干预措施: Clinical decision rule (Diagnostic Test)
Standard care
Patients in whom the general practitioner decides upon referral following local guidelines.
结局指标
主要结局
Hospital referral rate for acute chest pain
时间窗: 6 weeks after inclusion
hospital referral rate for acute chest pain compared between intervention and control group
Diagnostic accuracy of the clinical decision rule
时间窗: 6 months after inclusion
Diagnostic accuracy (i.e. sensitivity, negative predictive value) for ACS and major adverse cardiac events (MACE) MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.
Hospital referral rate for acute chest pain
时间窗: 24 hours after inclusion
hospital referral rate for acute chest pain compared between intervention and control group
Diagnostic accuracy of the clinical decision rule
时间窗: 24 hours after inclusion
Diagnostic accuracy (i.e. sensitivity, negative predictive value) for Acute Coronary Syndrome (ACS) and major adverse cardiac events (MACE). MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.
Diagnostic accuracy of the clinical decision rule
时间窗: 6 weeks after inclusion
Diagnostic accuracy (i.e. sensitivity, negative predictive value) for ACS and major adverse cardiac events (MACE) MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.
次要结局
- Diagnostic accuracy of the gut feeling/ presence of a sense of alarm from general practitioners(6 weeks after inclusion)
- Subgroup analyses for diagnostic accuracy of the clinical decision rule(6 months after inclusion)
- Adherence to the recommendations of the clinical decision rule by general practitioners (GP)(24 hours after inclusion)
- Patient reassurance measured by the State-Trait Anxiety Inventory(1 week after inclusion)
- Diagnostic accuracy of the HEART-score(6 weeks after inclusion)
- Subgroup analyses for hospital referral rate for acute chest pain(6 weeks after inclusion)
- Cost-effectiveness(6 months)
- Subgroup analyses for hospital referral rate for acute chest pain(24 hours after inclusion)
- Subgroup analyses for diagnostic accuracy of the clinical decision rule(24 hours after inclusion)
- Subgroup analyses for diagnostic accuracy of the clinical decision rule(6 weeks after inclusion)
研究者
Tobias N Bonten, MD PhD
Assistant professor
Leiden University Medical Center