Myocardial Infarction
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Radiometer Medical ApS
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is 21 years of age or older. * Subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study. * Subject is presenting to the ED with acute chest pain or equivalent ischemic symptoms suggestive of ACS or MI (e.g., acute chest pain/pressure, shortness of breath, discomfort in upper extremity, jaw or epigastrium, diaphoresis, nausea, vomiting, lightheadedness, dizziness, weakness, and/or syncope).
Exclusion criteria
* Subject is pregnant or may be pregnant. * Subject has an invalid written informed consent or has withdrawn consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of acute myocardial infarction (MI) | during the first 24 hours after presentation to the emergency department | 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. |
Countries
United States
Outcome results
None listed