Point of Care Evaluation of High-sensitivity Cardiac Troponin

Acute Coronary Syndrome Clinical Trial

— POC-ET  

Official title:

Point of Care Evaluation of High-sensitivity Cardiac Troponin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665127
• Other study ID #: AC21114
• Secondary ID: RG/20/10/34966
• Status: Recruiting
• Start date: November 16, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: April 2024
• Source: University of Edinburgh
• Contact: Chris Tuck
• Email: chris.tuck[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 30, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Locations

Country	Name	City	State
United Kingdom	NHS Lothian	Edinburgh

Sponsors (4)

Lead Sponsor	Collaborator
University of Edinburgh	British Heart Foundation, NHS Grampian, Siemens Healthcare Diagnostics Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time from presentation to rule-out or rule-in myocardial infarction		Time of index presentation until the time of reporting of the troponin result that rules in or rules out myocardial infarction, assessed up to the end of study follow up (12 months)
Other	Duration of stay in hospital (index)		Time from index presentation until the time of discharge from hospital, assessed up to the end of study follow up (12 months)
Other	Duration of stay in Emergency Department		Time from index presentation until the time of discharge from the Emergency Department, assessed up to the end of study follow up (12 months)
Other	Inter-assay coefficient of variation		During index admission, assessed up to 36 hours following enrolment
Primary	Type 1, 4b or 4c myocardial infarction or cardiac death		Index presentation to 30 days
Secondary	Any myocardial infarction		Index presentation to 1 year
Secondary	Cardiac death		Index presentation to 1 year
Secondary	Any myocardial infarction or cardiac death		Index presentation to 1 year
Secondary	Cardiovascular death		Index presentation to 1 year
Secondary	All-cause death		Index presentation to 1 year
Secondary	Reattendance with suspected acute coronary syndrome		Index presentation to 1 year
Secondary	Unplanned coronary revascularization		Following index presentation to 1 year