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POC-ET: Point of Care Evaluation of High-sensitivity Cardiac Troponin

Sponsor
University of Edinburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT05665127
Collaborator
British Heart Foundation (Other), NHS Grampian (Other), Siemens Healthcare Diagnostics Ltd (Other)
1,000
Enrollment
1
Location
29
Anticipated Duration (Months)
34.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Point of Care Evaluation of High-sensitivity Cardiac Troponin
    Actual Study Start Date :
    Nov 16, 2022
    Anticipated Primary Completion Date :
    May 16, 2024
    Anticipated Study Completion Date :
    Apr 16, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Type 1, 4b or 4c myocardial infarction or cardiac death [Index presentation to 30 days]

    Secondary Outcome Measures

    1. Any myocardial infarction [Index presentation to 1 year]

    2. Cardiac death [Index presentation to 1 year]

    3. Any myocardial infarction or cardiac death [Index presentation to 1 year]

    4. Cardiovascular death [Index presentation to 1 year]

    5. All-cause death [Index presentation to 1 year]

    6. Reattendance with suspected acute coronary syndrome [Index presentation to 1 year]

    7. Unplanned coronary revascularization [Following index presentation to 1 year]

    Other Outcome Measures

    1. 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)]

    2. 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)]

    3. 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)]

    4. Inter-assay coefficient of variation [During index admission, assessed up to 36 hours following enrolment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NHS Lothian Edinburgh United Kingdom

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Nicholas Mills, University of Edinburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Edinburgh
    ClinicalTrials.gov Identifier:
    NCT05665127
    Other Study ID Numbers:
    • AC21114
    • RG/20/10/34966
    First Posted:
    Dec 27, 2022
    Last Update Posted:
    Dec 27, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acute Coronary Syndrome

    Study Results

    No Results Posted as of Dec 27, 2022