Clinical Performance Evaluation of AQT90 FLEX TnI and TnT

Status:	Active, not recruiting
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	21 - Any
Updated:	5/10/2017
Start Date:	January 2016
End Date:	May 2017

AQT90 FLEX TnI and TnT - Clinical Sensitivity and Specificity Study

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.

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- Subject has an invalid written informed consent or has withdrawn consent.

We found this trial at

sites

Indiana University Health Ball Memorial Hospital

Muncie, Indiana 47303

Principal Investigator: Jan R. Kornilow, MD

from

Muncie, IN