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Completed

NCT Number: NCT01852123

High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome

In patients with chest pain the diagnosis of a heart attack (myocardial infarction) is made where there is evidence of heart muscle damage using a blood test to measure the heart muscle protein troponin. A new a more sensitive troponin test may help us to identify patients with myocardial infarction more easily.

The investigators propose to evaluate whether use of a novel high-sensitivity troponin test to lower the threshold for diagnosis of myocardial infarction is appropriate. If increased sensitivity does not reduce specificity for the diagnosis, then this new test will improve patient outcome through better targeting of therapies for coronary heart disease. However, if increased sensitivity leads to poor specificity, then patients may be misdiagnosed and given inappropriate cardiac medications with potentially detrimental outcomes.

In ten secondary and tertiary care hospitals across Scotland, the investigators will undertake a stepped wedge cluster randomized controlled trial of the implementation of a novel high-sensitivity troponin test. The primary end-point will be the one-year rate of cardiovascular death or recurrent myocardial infarction. This will establish whether the introduction of this high-sensitivity troponin test into routine clinical practice is beneficial to patient management and outcomes.

A subset of patients will be asked to give consent for inclusion into a sub-study that will permit storage of blood samples and will require the completion of a survey during the index admission and after 6 and 12 months of follow up.

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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

  • Suspected acute coronary syndrome
  • Troponin I measurement as part of routine clinical care

Exclusion criteria

  • None

Treatment and study plan

High-sensitivity troponin I assay

Device

Other names: ARCHITECT STAT high-sensitive troponin I assay

Primary outcomes

  1. Recurrent myocardial infarction or cardiovascular death at 1 year

    Time frame: 1 year

Secondary outcomes

  1. Duration of stay

    Time frame: Initial episode

    Duration of the index hospital stay, an expected average of 2 weeks

  2. Recurrent myocardial infarction

    Time frame: 1 year

  3. Unplanned coronary revascularization

    Time frame: 1 year

  4. Cardiovascular death

    Time frame: 1 year

  5. All cause death

    Time frame: 1 year

  6. Heart failure hospitalization

    Time frame: 1 year

  7. Major hemorrhage

    Time frame: 1 year

  8. Minor hemorrhage

    Time frame: 1 year

  9. Recurrent unplanned hospitalization excluding acute coronary syndrome

    Time frame: 30 days

  10. Non-cardiovascular death

    Time frame: 1 year

Other outcomes

  1. Physician diagnosis on discharge

    Time frame: Duration of the index hospital stay, an expected average of 2 weeks

  2. Sensitivity and specificity of sex-specific thresholds for the diagnosis of myocardial infarction

    Time frame: 3 months

  3. Evaluate thresholds to rule out myocardial infarction on presentation and change criteria to rule in myocardial infarction with serial sampling.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Abbott Diagnostics Division
  • NHS Greater Glasgow and Clyde
  • NHS Lothian

Registry information

Official study title

High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome: A Randomized Controlled Trial

Acronym: High-STEACS

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 13, 2013
Registry last updated
Jun 24, 2021

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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