Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes

Study Overview
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Brief Summary
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Hypothesis: High sensitivity cTnI assays will have improved diagnostic accuracy for type 1 MI compared to contemporary cTnI assays. The primary objective of the study is to determine the performance of a high sensitivity cardiac troponin I (hs-cTnI) assay compared to a contemporary cTnI assay for the diagnostic accuracy of type 1 acute myocardial infarction (AMI). The diagnostic performance of Abbott's hs-cTnI assay will be evaluated. Investigators will assess the assay's ability to diagnose AMI earlier and to rule out AMI earlier. The sensitivity, specificity, positive predictive value and negative predictive value of the hs-cTnI assay will be evaluated with both a universal cut off as well as with gender and potentially age derived 99th percentile upper reference limits (URL). Investigators will evaluate delta hs-cTnI values (pre-specified absolute concentration and percent changes over time) for their ability to contribute to the negative predictive value and hence potentially lead to an earlier rule out of AMI (improved specificity). Additionally, investigators will assess delta changes of the hs-cTnI assay for their potential contribution to the clinical differentiation of type 1 and type 2 (supply demand mismatch) MIs. Lastly, investigators will compare the diagnosis of AMI based on the currently used contemporary assay to the hs-assay, to assess both the incidence of AMI as well as for the time to diagnosis.

Official Title
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Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes

Conditions
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Acute Coronary Syndrome, Myocardial Infarction, Troponin

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Two or more cTnI values ordered for any clinical indication with specimen available for hs cTnI assay 18 years of age or older EKG done on admission / presentation Agree to research disclosure Exclusion Criteria: Admission through any venue other an emergency department Repeat admission for the same patient, only primary admission will be assessed Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UTROPIA study cohort<br>At least two cTnI data points available (including baseline) with blood samples available for hs-cTnI testing. No intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Acute Myocardial Infarction | Adjudicated diagnosis of acute myocardial infarction (AMI) to systematize the potentially earlier (0,3,6h) detection of AMI using the Abbott hs cTnI assay. | Up to 6 months after last enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In- hospital mortality |  | Up to 6 months after last enrollment | 
| 180 day mortality |  | Up to 6 months after last enrollment | 
| Repeat Cardiac hospitalization |  | Up to 6 months after last enrollment | 
| Time to repeat cardiac hospitalization |  | Up to 6 months after last enrollment | 
| ACS Diagnosis |  | Up to 6 months after last enrollment | 
| Repeat revascularization (bypass surgery versus percutaneous revascularization) |  | Up to 6 months after last enrollment | 
| Emergency encounter for chest pain |  | Up to 6 months after last enrollment | 
| New diagnosis of Congestive Heart Failure |  | Up to 6 months after last enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prospective cohort study, Diagnostic accuracy, High sensitivity versus contemporary troponin I assay, Gender, Renal Function