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The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study

Sponsor
Manchester University NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT03561051
Collaborator
National Institute for Health Research, United Kingdom (Other), Abbott Point of Care (Industry), LumiraDx (Industry), Roche Diagnostics (Industry)
700
Enrollment
13
Locations
43
Anticipated Duration (Months)
53.8
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to assess whether a decision aid that is currently used in hospitals across Greater Manchester to determine how likely it is that a patient has a serious heart problem is still accurate in the pre-hospital environment.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Investigators will aim to recruit up to 700 participants, aged 18-100, who call 999 with a complaint of chest pain and are subsequently attended by the ambulance service. A blood sample will be taken in the ambulance as well as information about the participant's symptoms, past medical history, physical examination findings and heart tracing findings. The participant will then be transferred to hospital, where another blood sample will be taken. Both of these blood samples will be analysed at a later date for the cardiac marker, troponin.

    Participants will then be followed up after 30 days via screening of their clinical records and contacting their GP. The investigators will gather information on the participant's initial admission to hospital, as well as any further hospital admissions and investigations that have occurred within the 30 days since this admission. The information collected will include data on serial cardiac marker testing; other laboratory analyses; length of stay; all imaging investigations and procedures; and details of any haemorrhagic complications.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Pre-hospital Evaluation of Sensitive Troponin (PRESTO) Study
    Actual Study Start Date :
    Feb 28, 2019
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Diagnosis of acute myocardial infarction [30 days]

    Secondary Outcome Measures

    1. Incident major adverse cardiac events [30 days]

    2. Prevalent acute myocardial infarction [30 days]

    3. Final diagnosis of participant [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult patients (>18 years)

    • Called 999 for an emergency ambulance because they have experienced pain, discomfort or pressure in the chest, epigastrium, neck, jaw or upper limb without an apparent non-cardiac source

    • Treating paramedic suspects these symptoms may be caused by acute coronary syndromes.

    Exclusion Criteria:

    • Patients with unequivocal evidence of ST elevation myocardial infarction who are being immediately transferred for primary percutaneous coronary intervention

    • Patients in whom an alternative diagnosis (other than acute coronary syndromes) is suspected, which would necessitate transfer to hospital

    • Patients who have not experienced symptoms in the previous 24 hours

    • Patients who lack the capacity to provide written informed consent, either because they lack the mental capacity to provide written informed consent or because effective communication is not possible (e.g. non-English speakers in the absence of adequate translation services)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bolton NHS Foundation Trust Bolton United Kingdom
    2 North West Ambulance Service NHS Trust Bolton United Kingdom
    3 North Bristol NHS Trust Bristol United Kingdom
    4 University Hospitals Coventry and Warwickshire NHS Trust Coventry United Kingdom
    5 West Midlands Ambulance Service NHS Foundation Trust Dudley United Kingdom
    6 Royal Devon and Exeter NHS Foundation Trust Exeter United Kingdom
    7 South Western Ambulance Service NHS Foundation Trust Exeter United Kingdom
    8 Manchester University NHS Foundation Trust Manchester United Kingdom
    9 Plymouth Hospitals NHS Trust Plymouth United Kingdom
    10 Salford Royal NHS Foundation Trust Salford United Kingdom
    11 Taunton and Somerset NHS Foundation Trust Taunton United Kingdom
    12 South Warwickshire NHS Foundation Trust Warwick United Kingdom
    13 Wrightington, Wigan and Leigh NHS Foundation Trust Wigan United Kingdom

    Sponsors and Collaborators

    • Manchester University NHS Foundation Trust
    • National Institute for Health Research, United Kingdom
    • Abbott Point of Care
    • LumiraDx
    • Roche Diagnostics

    Investigators

    • Principal Investigator: Richard Body, Manchester University NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Manchester University NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT03561051
    Other Study ID Numbers:
    • B00041
    • 223790
    First Posted:
    Jun 19, 2018
    Last Update Posted:
    Dec 27, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Manchester University NHS Foundation Trust
    T-MACS
    Pre-hospital environment
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Myocardial Infarction
    Chest Pain

    Study Results

    No Results Posted as of Dec 27, 2021