TWITCH-ED: Switching From Cardiac Troponin I to T

Sponsor

University of Edinburgh (Other)

Overall Status

Recruiting

CT.gov ID

NCT05748691

Collaborator

(none)

9,600

Enrollment

Location

Anticipated Duration (Months)

266.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Acute Myocardial Infarction Acute Myocardial Ischemia Myocardial Injury Chest Pain Heart Failure	Diagnostic Test: Clinical implementation of hs-cTnT

Study Design

Study Type:

Observational

Anticipated Enrollment :

9600 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Oct 25, 2020

Anticipated Primary Completion Date :

Oct 25, 2023

Anticipated Study Completion Date :

Oct 25, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Proportion of patients with suspected acute coronary syndrome admitted to hospital [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 Outcome Measures

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