Clinical Performance Evaluation of AQT90 FLEX TnI and TnT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1743 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

Eligibility Criteria

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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).