COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial

Study Overview
=================
Brief Summary
-----------------
Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.

Detailed Description
-----------------
Background: Comparative studies addressing the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in consecutive patients presenting to a United States (US) emergency department are lacking. Study objective: Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication. Null Hypothesis: hs-cTnI and or hs-cTnT assays will offer comparable diagnostic performance for acute myocardial injury and acute myocardial

Official Title
-----------------
COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial

Conditions
-----------------
Acute Myocardial Infarction, Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Cardiac troponin testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, defined as subject 18 years of age or older Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial cTnI measurement. At least one 12-lead electrocardiogram Exclusion Criteria: Currently pregnant Trauma related admission Cardiac arrest Decline to participate Did not present through the ED Transferred from an outside hospital

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 |
| --- | --- |
| Study population<br>Prospective, observational cohort study of consecutives patients (goal, 2000 patients over 5 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction. | Diagnostic Test: Cardiac troponin testing<br>* Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction. | Diagnostic performance of cardiac troponin assays for the diagnosis of acute myocardial injury and myocardial infarction | on admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Any death | Up to 180-days | 
| Cardiac death | Death due to cardiac reasons. | Up to 180-days | 
| Unstable angina | Diagnosis of unstable angina per chart review up to 180-days | Up to 180-days | 
| Acute myocardial infarction | Diagnosis of Acute myocardial infarction per chart review up to 180 days. | Up to 180-days | 
| Revascularization | Coronary artery bypass graft surgery or percutaneous coronary intervention | Up to 180-days | 
| Safety outcome: Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure. | Safety outcome for tested diagnostic strategies will be defined at 30-days, including index hospitalization events for MACE - Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure. | 30-days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
troponin, high-sensitivity cardiac troponin, acute myocardial infarction