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OpenTrials
Completed

NCT Number: NCT02624024

Clinical Performance Evaluation of AQT90 FLEX TnI and TnT

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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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Honor Health Scottsdale Osborn Medical Center, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Subject has an invalid written informed consent or has withdrawn consent.

Treatment and study plan

Primary outcomes

  1. Diagnosis of acute myocardial infarction (MI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Radiometer Medical ApS

Industry

Registry information

Official study title

AQT90 FLEX TnI and TnT - Clinical Sensitivity and Specificity Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2015
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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