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This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating emergency departments with symptoms suggestive of acute coronary syndrome (ACS)
This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating Emergency Departments (EDs) with symptoms suggestive of ACS and/or myocardial ischemia. Subjects presenting with symptoms suggestive of ACS will be screened and approached for consent for study enrollment by trained personnel.
After obtaining written informed consent, subjects will have up to 4 blood samples collected for cTnI testing using the Meritas Troponin I test and Meritas point-of-care (POC) Analyzer. Blood draws and testing will occur at 4 intervals over 24 hours.
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance of the Meritas Troponin I test | Clinical performance indicators (Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) and their respective 95 % confidence intervals (CIs) will be calculated for the quantitative determination of cardiac troponin I (cTnI) for use as an aid in the diagnosis of myocardial infarction (MI) | 24-hours |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic capability of sponsor's Meritas Troponin I to predict mortality (all-cause death) and cardiac events (i.e., MI, cardiac death). | Kaplan-Meier survival curves and risk ratios. A multivariate Cox proportional model with known risk factors as covariates in addition to the Troponin test result will be included in the data analysis | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 1000 to 1500 adult subjects presenting to emergency departments (ED) with symptoms suggestive of acute coronary sydrome (ACS) and/or myocardial ischemia
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| Name | Affiliation | Role |
|---|---|---|
| Jim Rock | Trinity Biotech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital & Trauma Center | San Francisco | California | 94110 | United States | ||
| University of Florida |
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EDTA Whole Blood
| Gainesville |
| Florida |
| 32608 |
| United States |
| Eastern Idaho Regional Medical Center | Idaho Falls | Idaho | 83404 | United States |
| Kentucky Clinical Trials Laboratories | Louisville | Kentucky | 40202 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Hennepin County Medical Ctr | Minneapolis | Minnesota | 55404 | United States |
| Sunrise Hospital | Las Vegas | Nevada | 89109 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28293 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Thomas Jefferson Univeristy | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Ben Taub | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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