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

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome; Myocardial Infarction
• Interventions: Device: High-sensitivity troponin I assay

• Registration Number: NCT01852123
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-13
• Study Start: 2013-06-10
• Primary Completion: 2017-03-03
• Study Completion: 2017-03-03
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48282

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Early implementation	High-sensitivity troponin I assay	The high-sensitivity troponin I assay will be implemented after a 6 month validation phase
Late implementation	High-sensitivity troponin I assay	The high-sensitivity troponin I assay will be implemented after a 12 month validation phase

Primary Outcome Measures

Name	Time	Method
Recurrent myocardial infarction or cardiovascular death at 1 year	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Lothian, United Kingdom