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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01852123
Acronym
High-STEACS
Enrollment
48282
Registered
2013-05-13
Start date
2013-06-10
Completion date
2017-03-03
Last updated
2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Myocardial Infarction

Keywords

High-sensitivity troponin assay, Myocardial infarction, Unstable angina, Myocardial injury, Cluster randomized trial

Brief summary

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.

Interventions

DEVICEHigh-sensitivity troponin I assay

Sponsors

NHS Lothian
CollaboratorOTHER_GOV
NHS Greater Glasgow and Clyde
CollaboratorOTHER
Abbott Diagnostics Division
CollaboratorINDUSTRY
University of Edinburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\- None

Design outcomes

Primary

MeasureTime frame
Recurrent myocardial infarction or cardiovascular death at 1 year1 year

Secondary

MeasureTime frameDescription
Non-cardiovascular death1 year
Major hemorrhage1 year
Minor hemorrhage1 year
Recurrent unplanned hospitalization excluding acute coronary syndrome30 days
All cause death1 year
Duration of stayInitial episodeDuration of the index hospital stay, an expected average of 2 weeks
Recurrent myocardial infarction1 year
Unplanned coronary revascularization1 year
Cardiovascular death1 year
Heart failure hospitalization1 year

Other

MeasureTime frame
Physician diagnosis on dischargeDuration of the index hospital stay, an expected average of 2 weeks
Evaluate thresholds to rule out myocardial infarction on presentation and change criteria to rule in myocardial infarction with serial sampling.6 months
Sensitivity and specificity of sex-specific thresholds for the diagnosis of myocardial infarction3 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026