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

NCT ID: NCT01852123

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-10
• Study Completion Date: 2017-03-03

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Early implementation

The high-sensitivity troponin I assay will be implemented after a 6 month validation phase

Group Type: OTHER

High-sensitivity troponin I assay

Intervention Type: DEVICE

Late implementation

The high-sensitivity troponin I assay will be implemented after a 12 month validation phase

Group Type: OTHER

High-sensitivity troponin I assay

Intervention Type: DEVICE

Interventions

High-sensitivity troponin I assay

Intervention Type: DEVICE

Other Intervention Names

ARCHITECT STAT high-sensitive troponin I assay

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: collaborator

Abbott Diagnostics Division

INDUSTRY

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas L Mills, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Ian Ford, PhD

Role: STUDY_CHAIR

University of Glasgow

Locations

Royal Infirmary of Edinburgh

Edinburgh, Lothian, United Kingdom

Countries

United Kingdom

References

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Reference Type: DERIVED

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SP/12/10/29922

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

High-STEACS

Identifier Type: -

Identifier Source: org_study_id