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

June 18, 2021 updated by: University of Edinburgh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH16 4SB
        • Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion criteria:

- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Early implementation
The high-sensitivity troponin I assay will be implemented after a 6 month validation phase
Device: High-sensitivity troponin I assay
Other Names:
  • ARCHITECT STAT high-sensitive troponin I assay
OTHER: Late implementation
The high-sensitivity troponin I assay will be implemented after a 12 month validation phase
Device: High-sensitivity troponin I assay
Other Names:
  • ARCHITECT STAT high-sensitive troponin I assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrent myocardial infarction or cardiovascular death at 1 year
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Physician diagnosis on discharge
Time Frame: Duration of the index hospital stay, an expected average of 2 weeks
Duration of the index hospital stay, an expected average of 2 weeks
Sensitivity and specificity of sex-specific thresholds for the diagnosis of myocardial infarction
Time Frame: 3 months
3 months
Evaluate thresholds to rule out myocardial infarction on presentation and change criteria to rule in myocardial infarction with serial sampling.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian
NHS Greater Glasgow and Clyde
Abbott Diagnostics Division

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 10, 2013

Primary Completion (ACTUAL)

March 3, 2017

Study Completion (ACTUAL)

March 3, 2017

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (ESTIMATE)

May 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • High-STEACS
  • SP/12/10/29922 (OTHER_GRANT: British Heart Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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