Switching From Cardiac Troponin I to T (TWITCH-ED)

February 17, 2023 updated by: Nicholas Mills, University of Edinburgh

Trial of Switching High-sensitivity Cardiac Troponin Assays in Suspected Acute Coronary Syndrome: an Interrupted Time Series Analysis (TWITCH-ED Study)

Cardiac troponin is central to the diagnosis of myocardial infarction and high-sensitivity cardiac troponin (hs-cTn) assays are the preferred choice for the assessment of patients with suspected acute coronary syndrome.

Since the introduction of hs-cTn assays in Europe in 2010, most hospitals have switched from contemporary sensitive cardiac troponin assays to a hs-cTn assay. The implementation of hs-cTn assays has led to an increase in the number of patients identified with myocardial injury. Although both hs-cTnI and hs-cTnT assays are recommended in current guidelines, the impact of switching from a hs-cTnI assay to a hs-cTnT assay on clinical practice is unknown. At this point, no studies have evaluated the impact of implementing sex-specific hs-cTnT thresholds on the diagnosis of myocardial infarction and outcome in clinical practice.

The investigators propose to determine the proportion of patients with and without myocardial injury admitted to the hospital before and after implementation of a hs-cTnT assay and to evaluate the impact on investigations, care and clinical outcomes in consecutive patients with suspected acute coronary syndrome.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

9600

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SB
        • Recruiting
        • Centre for Cardiovascular Science
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients presenting to an Emergency Department or an Acute Medical Unit in NHS Lothian between October 25th 2020 and October 25th 2022 where the attending clinician measures cardiac troponin for suspected acute coronary syndrome will be identified by NHS Lothian staff or the research team using an existing screening tool embedded into the ordering of cardiac troponin testing.

We will compare the clinical impact of two guideline recommended high-sensitivity cardiac troponin assays in routine health care. We will not seek individual patient consent as this is an evaluation of a change in routine clinical care using approved tests, there are no specific research procedures, and we wish to evaluate performance in those patients in whom clinicians apply the test to avoid selection bias.

Description

Inclusion Criteria:

  • Age 18 years and over
  • Symptoms of possible acute coronary syndrome
  • High-sensitivity cardiac troponin measured at presentation

Exclusion Criteria:

  • Insufficient clinical information to perform record linkage
  • Previous enrolment in the study
  • Patients with ST-segment elevation myocardial infarction (STEMI)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-implementation group
Clinical use of hs-cTnI in patients with suspected acute coronary syndrome
Post-implementation group
Clinical use of hs-cTnT in patients with suspected acute coronary syndrome
Diagnostic test: Clinical implementation of hs-cTnT
To investigate the clinical impact on the transition from a hs-cTnI assay to a hs-cTnT assay in consecutive patients presenting to the Emergency Department or Acute Medical Unit with suspected acute coronary syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with suspected acute coronary syndrome admitted to hospital
Time Frame: Up to 24 hours
To determine the proportion of patients with and without myocardial injury admitted to the hospital before and after implementation of the hs-cTnT assay
Up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with myocardial injury admitted to hospital
Time Frame: Up to 24 hours
To determine the proportion of patients with myocardial injury admitted to hospital
Up to 24 hours
Length of hospital stay
Time Frame: Up to 30 days
To determine the length of hospital stay
Up to 30 days
Clinical diagnosis of myocardial infarction
Time Frame: Up to 24 hours
To determine the prevalence of myocardial infarction
Up to 24 hours
Clinical diagnosis of heart failure
Time Frame: Up to 24 hours
To determine the prevalence of heart failure
Up to 24 hours
Coronary angiography during hospital admission
Time Frame: Up to 30 days
To determine the number of coronary angiograms performed during hospital admission
Up to 30 days
Echocardiography during hospital admission
Time Frame: Up to 30 days
To determine the number of echocardiograms performed during hospital admission
Up to 30 days
New prescription of evidence-based treatment for coronary artery disease or heart failure following discharge
Time Frame: Up to 30 days
To determine the number of new prescriptions of evidence-based treatment for coronary artery disease or heart failure following discharge
Up to 30 days
Revascularization at 30 days and one year
Time Frame: 30 days and 1 year
To determine the rate of coronary revascularization at 30 days and one year
30 days and 1 year
Reattendance with suspected acute coronary syndrome at 30 days and one year
Time Frame: 30 days and 1 year
To determine the rate of reattendance with suspected acute coronary syndrome at 30 days and one year
30 days and 1 year
Subsequent myocardial infarction at 30 days and one year
Time Frame: 30 days and 1 year
To determine the prevalence of subsequent myocardial infarction at 30 days and one year
30 days and 1 year
Subsequent heart failure at 30 days and one year
Time Frame: 30 days and 1 year
To determine the prevalence of subsequent heart failure at 30 days and one year
30 days and 1 year
Subsequent myocardial infarction, heart failure or cardiovascular death at 30 days and one year
Time Frame: 30 days and 1 year
To determine the prevalence of subsequent myocardial infarction, heart failure or cardiovascular death at 30 days and one year
30 days and 1 year
Cardiovascular death at 30 days and one year
Time Frame: 30 days and 1 year
To determine the prevalence of cardiovascular death at 30 days and one year
30 days and 1 year
All-cause death at 30 days and one year
Time Frame: 30 days and 1 year
To determine the prevalence of all-cause death at 30 days and one year
30 days and 1 year

Collaborators and Investigators

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

Sponsor

University of Edinburgh

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)

October 25, 2020

Primary Completion (Anticipated)

October 25, 2023

Study Completion (Anticipated)

October 25, 2023

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DL-2022-046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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