VITROS Immunodiagnostic Products hs Troponin I

Study Overview
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Brief Summary
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The purpose of this clinical study is to collect data to substantiate the use of the VITROS hs Troponin I test as an aid in the diagnosis of myocardial infarction (MI). The test is further indicated for risk stratification of mortality, myocardial infarction or coronary revascularization in patients with acute coronary syndrome.

Detailed Description
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A prospective clinical sample collection and cardiac troponin I testing will be conducted in individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS) at geographically dispersed sites in the US. Individuals who meet the inclusion/exclusion criteria, including having signed an informed consent form will be included in the study. Clinical and laboratory data will be collected to demonstrate product performance compared to an adjudicated clinical diagnosis. Sample collection and testing of clinical samples with the VITROS hs Troponin I test will be performed under two separate protocols.

Official Title
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VITROS Immunodiagnostic Products hs Troponin I

Conditions
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Acute Coronary Syndrome (ACS), Myocardial Infarction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be ≥22 years of age at the time of consent. Subject presenting with symptoms suggestive of acute coronary syndrome including chest pain, or chest pain equivalent. Must have an Electrocardiogram (ECG) ordered as part of the subject's standard of care. Subject willing and able to provide informed consent. Exclusion Criteria: Subject is unable to comply with the study requirements. Any samples which were not obtained under IRB approved protocol.

Ages Eligible for Study
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Minimum Age: 22 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the VITROS hs Troponin I test | Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS). | VITROS hs Troponin I value at baseline | 
| Sensitivity and specificity of the VITROS hs Troponin I test | Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS). | VITROS hs Troponin I value > 1 hour and up to 3 hours | 
| Sensitivity and specificity of the VITROS hs Troponin I test | Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS). | VITROS hs Troponin I value at > 3 hours and up to 6 hours | 
| Sensitivity and specificity of the VITROS hs Troponin I test | Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS). | VITROS hs Troponin I value at > 6 hours and up to 9 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk stratification of subjects | Assess the use of cardiac Troponin I measurement in the risk stratification of subjects. | Up to 12 months after last enrollment | 
| Rule in and rule out myocardial infarction (MI) | Evaluate the VITROS hs Troponin I test to rule in and rule out MI. | VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Troponin