Point of Care Evaluation of High-sensitivity Cardiac Troponin (POC-ET)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Coronary Syndrome

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • Nhs Lothian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected acute coronary syndrome attending the Emergency Department or Acute Medical Unit

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Type 1, 4b or 4c myocardial infarction or cardiac death	Index presentation to 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Any myocardial infarction	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
All-cause death	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

Other Outcome Measures

Outcome Measure	Time Frame
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)
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)
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)
Inter-assay coefficient of variation	During index admission, assessed up to 36 hours following enrolment

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: British Heart Foundation; NHS Grampian; Siemens Healthcare Diagnostics Ltd
• Investigators: Principal Investigator: Nicholas Mills, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): February 28, 2025
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: AC21114; RG/20/10/34966 (Other Grant/Funding Number: British Heart Foundation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No