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Publication - Dr Jenny Ingram

    Randomised controlled trial of the Limit of Detection of Troponin and ECG Discharge (LoDED) strategy versus usual care in adult patients with chest pain attending the emergency department

    Study protocol

    Citation

    Carlton, E, Campbell, S, Ingram, J, Kandiyali, R, Taylor, HF, Aziz, S, Beresford, P, Kendall, J, Reuben, A, Smith, J, Vickery, PJ & Benger, JR, 2018, ‘Randomised controlled trial of the Limit of Detection of Troponin and ECG Discharge (LoDED) strategy versus usual care in adult patients with chest pain attending the emergency department: Study protocol’. BMJ Open, vol 8.

    Abstract

    Introduction
    Observational data suggest a single high-sensitivity troponin blood
    test taken at emergency department (ED) presentation could be used to
    rule out major adverse cardiac events (MACE) in 10%–60% of ED patients
    with chest pain. This is done using an ‘undetectable’ cut-off (the Limit
    of Detection: LoD). We combined the LoD cut-off with ECG findings to
    create the LoDED strategy. We aim to establish whether the LoDED
    strategy works under real-life conditions, when compared with existing
    strategies, in a way that is cost-effective and acceptable to patients.

    Methods and analysis
    This is a parallel-group pragmatic randomised controlled trial across
    UK EDs. Adults presenting to ED with suspected cardiac chest pain will
    be randomised 1:1. Existing rule-out strategies in current use across
    study centres, using serial high-sensitivity troponin testing, will be
    compared with the LoDED strategy. The primary outcome is successful
    early discharge (discharge from hospital within 4 hours of arrival)
    without MACE occurring within 30 days. Secondary outcomes include
    initial length of hospital stay; comparative costs; patient satisfaction
    and acceptability to patients. To detect a 9% difference between the
    early discharge rates (assuming an 8% rate in the standard care group)
    with 90% power, 594 patients need to be recruited, assuming a 95%
    follow-up rate.

    Ethics and dissemination
    The study has been approved by the Frenchay Research Ethics Committee
    (reference 18/SW/0038). Results will be published in an international
    peer-reviewed journal. Lay summaries will be made available to patients.

    Trial registration number
    ISRCTN86184521; Pre-results.

    Full details in the University publications repository