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Completed

NCT Number: NCT05748691

Switching From Cardiac Troponin I to T

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.

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Key information

Conditions

Acute Coronary Syndrome Acute Myocardial Infarction Acute Myocardial Ischemia Behavior Cardiovascular Diseases Chest Pain Coitus Heart Diseases Heart Failure Myocardial Injury Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sexual Behavior Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Cardiovascular Science

Edinburgh, EH16 4SB, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Clinical implementation of hs-cTnT

Diagnostic Test

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Length of hospital stay

    Time frame: Up to 30 days

    To determine the length of hospital stay

  3. Clinical diagnosis of myocardial infarction

    Time frame: Up to 24 hours

    To determine the prevalence of myocardial infarction

  4. Clinical diagnosis of heart failure

    Time frame: Up to 24 hours

    To determine the prevalence of heart failure

  5. Coronary angiography during hospital admission

    Time frame: Up to 30 days

    To determine the number of coronary angiograms performed during hospital admission

  6. Echocardiography during hospital admission

    Time frame: Up to 30 days

    To determine the number of echocardiograms performed during hospital admission

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

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

Acronym: TWITCH-ED

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2023
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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