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临床试验/NCT05665127
NCT05665127进行中(未招募)不适用

Point of Care Evaluation of High-sensitivity Cardiac Troponin

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,000
试验地点
1
主要终点
Type 1, 4b or 4c myocardial infarction or cardiac death

研究概览

简要总结

In this observational research project the investigators wish to test new technologies that could allow them to either detect or rule out heart attacks earlier.

Currently, when a patient attends the Emergency Department with symptoms that could be due to a heart attack, the patient has a blood test taken from a vein in the arm. This is sent to a laboratory to measure the level of a protein called troponin that is released from the heart when it is damaged. Doctors and nurses use the level of troponin measured in that blood sample, along with a tracing of the heart and an assessment of symptoms, to decide whether the patient is having a heart attack. On average, it takes about 2 hours from the patient arriving at hospital to the doctor or nurse receiving the blood test result so they can make this diagnosis.

A device has been designed that can measure troponin by using a drop of blood from a finger prick with the result available in around 10 minutes. This means that if a patient is having a heart attack we can diagnose it earlier and give them treatment. Previous studies have also showed that the majority of patients who attend hospital with chest pain ultimately do not have a heart attack. With this new device the investigators hope to be able to reassure these patients that their symptoms are not due to a heart attack, so the clinical team can concentrate on finding out what else could be causing their chest pain, and ultimately discharge them earlier.

The investigators aim to find the best way to use this new device and look at the impact this device has on the length of time from sample to diagnosis and time spent in hospital.

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

  • Presenting to hospital with symptoms of suspected acute coronary syndrome
  • Age 18 years and over

排除标准

  • Patients with ST-segment elevation on the electrocardiogram
  • Patients presenting with an out-of-hospital cardiac arrest
  • Patients unable or unwilling to give informed consent
  • Patients unable or unwilling to comply with study protocol
  • Previous enrolment in this study

结局指标

主要结局

Type 1, 4b or 4c myocardial infarction or cardiac death

时间窗: Index presentation to 30 days

次要结局

  • All-cause death(Index presentation to 1 year)
  • Cardiac death(Index presentation to 1 year)
  • Any myocardial infarction or cardiac death(Index presentation to 1 year)
  • Cardiovascular death(Index presentation to 1 year)
  • Any myocardial infarction(Index presentation to 1 year)
  • Reattendance with suspected acute coronary syndrome(Index presentation to 1 year)
  • Unplanned coronary revascularization(Following index presentation to 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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