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Switching From Cardiac Troponin I to T

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05748691
Acronym
TWITCH-ED
Enrollment
26000
Registered
2023-03-01
Start date
2020-10-25
Completion date
2023-10-25
Last updated
2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Acute Myocardial Infarction, Acute Myocardial Ischemia, Chest Pain, Heart Failure, Myocardial Injury

Keywords

Acute Coronary Syndrome, Acute Myocardial Infarction, Myocardial Injury, High-Sensitivity Cardiac Troponin T, High-Sensitivity Cardiac Troponin I, Biomarker, Acute Cardiovascular Care, Diagnostic Pathways, Outcomes, Sex, Sex-specific Thresholds, Upper Reference Limits

Brief summary

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.

Interventions

DIAGNOSTIC_TESTClinical 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.

Sponsors

University of Edinburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with suspected acute coronary syndrome admitted to hospitalUp to 24 hoursTo determine the proportion of patients with and without myocardial injury admitted to the hospital before and after implementation of the hs-cTnT assay

Secondary

MeasureTime frameDescription
Cardiovascular death at 30 days and one year30 days and 1 yearTo determine the prevalence of cardiovascular death at 30 days and one year
All-cause death at 30 days and one year30 days and 1 yearTo determine the prevalence of all-cause death at 30 days and one year
Proportion of patients with myocardial injury admitted to hospitalUp to 24 hoursTo determine the proportion of patients with myocardial injury admitted to hospital
Length of hospital stayUp to 30 daysTo determine the length of hospital stay
Clinical diagnosis of myocardial infarctionUp to 24 hoursTo determine the prevalence of myocardial infarction
Clinical diagnosis of heart failureUp to 24 hoursTo determine the prevalence of heart failure
Subsequent myocardial infarction, heart failure or cardiovascular death at 30 days and one year30 days and 1 yearTo determine the prevalence of subsequent myocardial infarction, heart failure or cardiovascular death at 30 days and one year
Echocardiography during hospital admissionUp to 30 daysTo determine the number of echocardiograms performed during hospital admission
New prescription of evidence-based treatment for coronary artery disease or heart failure following dischargeUp to 30 daysTo determine the number of new prescriptions of evidence-based treatment for coronary artery disease or heart failure following discharge
Revascularization at 30 days and one year30 days and 1 yearTo determine the rate of coronary revascularization at 30 days and one year
Reattendance with suspected acute coronary syndrome at 30 days and one year30 days and 1 yearTo determine the rate of reattendance with suspected acute coronary syndrome at 30 days and one year
Subsequent myocardial infarction at 30 days and one year30 days and 1 yearTo determine the prevalence of subsequent myocardial infarction at 30 days and one year
Subsequent heart failure at 30 days and one year30 days and 1 yearTo determine the prevalence of subsequent heart failure at 30 days and one year
Coronary angiography during hospital admissionUp to 30 daysTo determine the number of coronary angiograms performed during hospital admission

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026