Point of Care Evaluation of High-sensitivity Cardiac Troponin

NCT05665127 | Active Not Recruiting

• 2 other identifiers: AC21114RG/20/10/34966
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

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

  Index presentation to 30 days

Secondary Outcomes (7)

• 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

Other Outcomes (4)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Grampian: collaborator
• Siemens Healthcare Diagnostics Ltd: collaborator
• University of Edinburgh: lead
• British Heart Foundation: collaborator

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Nicholas Mills

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 27, 2022
• Study Start: November 16, 2022
• Primary Completion: February 28, 2025
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

GB (1)