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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Coronary Syndrome, Myocardial Infarction

Intervention / Treatment
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* Device: High-sensitivity troponin I assay


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Suspected acute coronary syndrome Troponin I measurement as part of routine clinical care Exclusion criteria: - None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Early implementation<br>The high-sensitivity troponin I assay will be implemented after a 6 month validation phase | Device: High-sensitivity troponin I assay<br> <br> * Other names: ARCHITECT STAT high-sensitive troponin I assay;|
| Other: Late implementation<br>The high-sensitivity troponin I assay will be implemented after a 12 month validation phase | Device: High-sensitivity troponin I assay<br> <br> * Other names: ARCHITECT STAT high-sensitive troponin I assay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent myocardial infarction or cardiovascular death at 1 year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of stay | Duration of the index hospital stay, an expected average of 2 weeks | Initial episode | 
| Recurrent myocardial infarction |  | 1 year | 
| Unplanned coronary revascularization |  | 1 year | 
| Cardiovascular death |  | 1 year | 
| All cause death |  | 1 year | 
| Heart failure hospitalization |  | 1 year | 
| Major hemorrhage |  | 1 year | 
| Minor hemorrhage |  | 1 year | 
| Recurrent unplanned hospitalization excluding acute coronary syndrome |  | 30 days | 
| Non-cardiovascular death |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-sensitivity troponin assay, Myocardial infarction, Unstable angina, Myocardial injury, Cluster randomized trial