Switching From Cardiac Troponin I to T

Completed

• Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction; Chest Pain; Myocardial Injury; Acute Myocardial Ischemia; Heart Failure
• Interventions: Diagnostic Test: Clinical implementation of hs-cTnT

• Registration Number: NCT05748691
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-25
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-03-01
• Primary Completion: 2023-10-25
• Study Completion: 2023-10-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-implementation group	Clinical implementation of hs-cTnT	Clinical use of hs-cTnT in patients with suspected acute coronary syndrome

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Length of hospital stay	Up to 30 days	To determine the length of hospital stay
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
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
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
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
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
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
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
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
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

Trial Locations

Locations (1)

Centre for Cardiovascular Science; 🇬🇧 Edinburgh, United Kingdom