Switching From Cardiac Troponin I to T

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Diagnostic Test: Clinical implementation of hs-cTnT


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-implementation group<br>Clinical use of hs-cTnI in patients with suspected acute coronary syndrome | |
| Post-implementation group<br>Clinical use of hs-cTnT in patients with suspected acute coronary syndrome | Diagnostic Test: Clinical implementation of hs-cTnT<br>* 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.<br>|

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 | 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 | To determine the proportion of patients with myocardial injury admitted to hospital | Up to 24 hours | 
| Length of hospital stay | To determine the length of hospital stay | Up to 30 days | 
| Clinical diagnosis of myocardial infarction | To determine the prevalence of myocardial infarction | Up to 24 hours | 
| Clinical diagnosis of heart failure | To determine the prevalence of heart failure | Up to 24 hours | 
| Coronary angiography during hospital admission | To determine the number of coronary angiograms performed during hospital admission | Up to 30 days | 
| Echocardiography during hospital admission | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | To determine the prevalence of all-cause death at 30 days and one year | 30 days and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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