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Completed

NCT Number: NCT03005158

High-Sensitivity Cardiac Troponin On Presentation to Rule Out Myocardial Infarction

Patients with suspected acute coronary syndrome account for a tenth of all presentations to the Emergency Department and up to 40 per cent of unplanned hospital admissions. The majority of patients do not have a heart attack (myocardial infarction), and may be safely discharged from the Emergency Department.

The investigators propose to evaluate whether the use of the HighSTEACS pathway in patients with suspected acute coronary syndrome reduces length of stay and allows more patients to be safely discharged from the Emergency Department. This pathways utilizes high-sensitivity cardiac troponin I testing and will rule out myocardial infarction if troponin concentrations are <5 ng/L on presentation, with further testing indicated at 3 hours only in those presenting early or with troponin concentrations between 5 ng/L and the 99th centile.

In six secondary and tertiary centres across Scotland, the investigators will introduce the pathway as part of a stepped wedge cluster randomized controlled trial. Sequential hypothesis testing will evaluate the efficacy and safety of the pathway. The primary efficacy end-point will be length of stay from time of presentation until final hospital discharge and the primary safety end-point will be survival free from type 1 or 4b myocardial infarction or cardiac death from discharge to 30 days. The study population will consist of those patients with cardiac troponin concentrations within the normal reference range (<99th centile) at presentation.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All consecutive patients with suspected acute coronary syndrome
  • High-sensitivity cardiac troponin I measured as part of routine clinical care

Exclusion criteria

  • Patients who are not resident in Scotland
  • Patients with ST-segment elevation myocardial infarction
  • Patients presenting to hospital in cardiac arrest
  • Patients with presentation high-sensitivity cardiac troponin I concentrations greater than sex-specific 99th centile thresholds

Treatment and study plan

Validation Phase

Other

Standard care across all sites during the validation phase will rule out myocardial infarction in those with presentation troponin below the 99th centile with greater than 6 hours of symptoms at the time of blood sampling. In those with less than 6 hours of symptoms, a second test will be measured 6- 12 hours after presentation.

Randomization Phase

Other

Standard care or HighSTEACS pathway.

Implementation Phase

Other

Implementation of the HighSTEACS pathway to rule out myocardial infarction in patients with suspected acute coronary syndrome. Myocardial infarction will be ruled out if presentation cardiac troponin concentrations are <5 ng/L in those with at least 2 hours of symptoms at the time of blood sampling. In patients with less than two hours of symptoms, or where cardiac troponin concentrations are between 5ng/L and the 99th centile, repeat testing will be recommended at 3 hours. Myocardial infarction will be ruled out at 3 hours if cardiac troponin concentrations are unchanged (<3 ng/L change) and remain ≤99th centile on retesting. Those remaining ≤99th centile on retesting but demonstrating a significant change will require admission for further testing at 6-12 hours.

Primary outcomes

  1. Length of hospital stay (minutes)

    Time frame: Length of time from initial presentation to the Emergency Department until final discharge from hospital, an average of 24 hours.

    This time frame is unique to each patient

  2. Type 1 or type 4b myocardial infarction or cardiac death after discharge and within 30 days of index admission

    Time frame: Hospital discharge to 30 days after initial presentation

Secondary outcomes

  1. Proportion of patients discharged directly home from the Emergency Department

    Time frame: Presentation to discharge from hospital, an average of 24 hours.

    Time frame of initial hospital episode is unique to each patient

  2. Type 1 or 4b Myocardial Infarction after hospital discharge (independently double adjudicated using all available clinical information)

    Time frame: Hospital discharge to 30 days and 1 year after initial presentation

    An adjudicated diagnosis of type 1 and type 4b myocardial infarction will be made in line with the universal definition of myocardial infarction, using all available clinical information.

  3. Cardiac death after hospital discharge (independently double adjudicated using all available clinical information)

    Time frame: Hospital discharge to 30 days and 1 year after initial presentation

  4. Cardiovascular death after hospital discharge (independently double adjudicated using all available clinical information)

    Time frame: Hospital discharge to 30 days and 1 year after initial presentation

  5. All-cause death after hospital discharge

    Time frame: Hospital discharge to 30 days and 1 year after initial presentation

  6. Unplanned coronary revascularisation after hospital discharge (from cardiac intervention databases and case note review)

    Time frame: Hospital discharge to 30 days and 1 year after initial presentation

    We will identify any patients who require unplanned percutaneous coronary intervention or coronary artery bypass grafting.

  7. Proportion of patients re-attending the Emergency Department

    Time frame: Hospital discharge to 30 days and 1 year after initial presentation

Other outcomes

  1. Pre-specified sub-group analyses of the primary outcome

    Time frame: length of hospital stay defined as the length of time from initial presentation to the Emergency Department until final discharge from hospital; safety follow-up time frame of 30 days and 1 year after hospital discharge

    We will evaluate if the effect of intervention is significantly stronger or weaker in pre-specified sub-groups by assessing the co-primary endpoints in those who present with cardiac troponin <5 ng/L (low risk group), and in the whole population across different ages (considering age as a continuous variable), by duration of symptoms (considered as a continuous variable), by gender, by those who have or do not have a pre-existing history of ischaemic heart disease, by those with a presentation electrocardiogram suggesting ischaemia, by the GRACE risk score (considered as a continuous variable), and by day of patient presentation (assessing differences in weekday/weekend or routine/out-of-hours presentation).

  2. Cost-effectiveness analysis

    Time frame: 1 year

    Based on costs of investigation and management in the year after initial hospital presentation

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Greater Glasgow and Clyde
  • NHS Lothian

Registry information

Official study title

High-Sensitivity Cardiac Troponin On Presentation to Rule Out Myocardial Infarction (HiSTORIC): A Stepped Wedge Cluster Randomized Trial

Acronym: HiSTORIC

Important dates

Study start
2014
Primary completion
2017
Study completion
2021
First posted
Dec 29, 2016
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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