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The AQT90 FLEX Troponin I (TnI) and Troponin T (TnT) Tests are in vitro diagnostic assays intended as an aid in the diagnosis of myocardial infarction (MI) in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX TnI and TnT assays for both whole blood and plasma in the intended use population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute chest pain or equivalent ischemic symptoms | acute chest pain or equivalent ischemic symptoms suggestive of acute coronary syndromes (ACS) or acute myocardial infarction (MI) |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of acute myocardial infarction (MI) | Diagnosis of acute myocardial infarction (MI) that a subject was experiencing at the time of the subject's presentation to the ED, as determined by independent adjudication panel and based on the Third Universal Definition of Myocardial Infarction. | during the first 24 hours after presentation to the emergency department |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects 21 years of age or older presenting to the emergency department (ED) with acute chest pain or equivalent ischemic symptoms suggestive of acute coronary syndromes (ACS) or acute myocardial infarction (MI).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health Scottsdale Osborn Medical Center | Scottsdale | Arizona | 85251 | United States | ||
| Honor Health Scottsdale Shea Medical Center |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Frozen plasma samples are retained for this study and possible future studies.
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Indiana University Health Ball Memorial Hospital | Muncie | Indiana | 47303 | United States |
| UMASS Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| University of Cincinnati Department of Emergency Medicine | Cincinnati | Ohio | 45267 | United States |
| Catholic Health Initiatives Institute for Research and Innovation -CHI Franciscan Health | Tacoma | Washington | 98405 | United States |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |