Clinical Performance Evaluation of AQT90 FLEX TnI and TnT

Completed

Conditions studied: Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT02624024

Run by

Radiometer Medical ApS

People needed

1743

Starts

2016-01-01

Expected to finish

2017-06-01

Last updated by the study team

2017-07-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Subject is pregnant or may be pregnant.
• Subject has an invalid written informed consent or has withdrawn consent.

Where it is running

• Honor Health Scottsdale Osborn Medical Center — Scottsdale, Arizona, United States
• Honor Health Scottsdale Shea Medical Center — Scottsdale, Arizona, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Indiana University Health Ball Memorial Hospital — Muncie, Indiana, United States
• UMASS Memorial Medical Center — Worcester, Massachusetts, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• University of Cincinnati Department of Emergency Medicine — Cincinnati, Ohio, United States
• Catholic Health Initiatives Institute for Research and Innovation -CHI Franciscan Health — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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