Troponin-only Manchester Acute Coronary Syndromes Decision Aid to Reduce Unnecessary Hospitalisation for Patients With Chest Pain: a Randomized, Controlled Point of Care Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The incidence of major adverse cardiac event
研究概览
简要总结
The aim of the study is to establish whether the safety of the T-MACS decision aid to immediately 'rule out' acute coronary syndromes with one blood sample for the cardiac damage marker troponin, is non-inferior to an approach requiring serial troponin sampling over three hours.
详细描述
We will conduct a randomized, controlled point of care trial embedded in routine practice. We will ask clinicians to obtain written informed consent during the course of their clinical duties. Patients who have suspected cardiac chest pain, who are identified as being at very low risk by the T-MACS algorithm, will be invited to participate.
Patients will then be randomly allocated to be advised that they can be discharged immediately (so long as the doctor and patient have no other concerns; this is the originally intended use of T-MACS; intervention arm) or to receive a second blood test after 3 hours (current practice; control arm).
Participants will then be followed up by electronic record review after 30 days and 12 months. Other than the difference in the requirement for a second blood test, participants will not notice any change to their care.
The accelerated pathway (involving a single blood test) has been shown to be safe in observational research involving over 5,000 patients. All of the data that are collected are the same of those that are collected in routine care, and they will be anonymised for analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •Presents to the Emergency Department with pain, discomfort or pressure in the chest, epigastrium, neck, jaw, or upper limb without an apparent non-cardiac source which the treating physician believes warrants investigation for possible acute coronary syndrome
- •The patient is identified as being at 'very low risk' by the T-MACS decision aid following a single hs-cTn test at the time of arrival in the Emergency Department
排除标准
- •No capacity to provide informed consent
- •Inability to communicate in English language if translation services are unavailable
- •Patient is a prisoner
- •No NHS number (precluding electronic follow up)
结局指标
主要结局
The incidence of major adverse cardiac event
时间窗: 30 days
This is defined as cardiovascular death or acute myocardial infarction (including prevalent acute myocardial infarction at the time of initial attendance)
次要结局
- The incidence of cardiovascular death or acute myocardial infarction(1 year)
- The incidence of coronary revascularization(30 days)
- Length of initial hospital stay(30 days)