Clinical Performance Evaluation of AQT90 FLEX TnI and TnT

Radiometer

Status: Completed

Conditions: Myocardial Infarction

Study type: Observational

Funder types: Industry

Identifiers

NCT02624024

DC-059975

Details and patient eligibility

About

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.

Enrollment: 1,743 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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• Subject has an invalid written informed consent or has withdrawn consent.

Trial design

1,743 participants in 1 patient group

Acute chest pain or equivalent ischemic symptoms

Description:

acute chest pain or equivalent ischemic symptoms suggestive of acute coronary syndromes (ACS) or acute myocardial infarction (MI)