Clinical Performance Evaluation of AQT90 FLEX TnI and TnT

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT02624024
• Lead Sponsor: Radiometer Medical ApS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-08
• Study Start: 2016-01
• Status Verified: 2017-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1743

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).

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Exclusion Criteria

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• Subject has an invalid written informed consent or has withdrawn consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Honor Health Scottsdale Osborn Medical Center; 🇺🇸 Scottsdale, Arizona, United States

Honor Health Scottsdale Shea Medical Center; 🇺🇸 Scottsdale, Arizona, 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