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CompletedNCT02624024Updated Jul 2, 2017

Clinical Performance Evaluation of AQT90 FLEX TnI and TnT

An observational study in Myocardial Infarction, sponsored by Radiometer Medical ApS. Completed at 8 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by Radiometer Medical ApS · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,743
Ages
21 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Myocardial Infarction
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In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 1,743 is above the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Radiometer Medical ApS is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects 21 years of age or older presenting to the emergency department (ED) with acute chest pain or equivalent ischemic symptoms suggestive of acute coronary syndromes (ACS) or acute myocardial infarction (MI).

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

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,743 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Acute chest pain or equivalent ischemic symptoms

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

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What researchers measure

Primary outcomes

  1. Diagnosis of acute myocardial infarction (MI)

    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.

    Time frame: during the first 24 hours after presentation to the emergency department

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Study locations

8 sites
  • Honor Health Scottsdale Osborn Medical Center
    Scottsdale, Arizona 85251, United States
  • Honor Health Scottsdale Shea Medical Center
    Scottsdale, Arizona 85258, United States
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
  • Indiana University Health Ball Memorial Hospital
    Muncie, Indiana 47303, United States
  • UMASS Memorial Medical Center
    Worcester, Massachusetts 01655, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • University of Cincinnati Department of Emergency Medicine
    Cincinnati, Ohio 45267, United States
  • Catholic Health Initiatives Institute for Research and Innovation -CHI Franciscan Health
    Tacoma, Washington 98405, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02624024
Lead sponsor
Radiometer Medical ApS
Responsible party
Sponsor
First posted
Dec 8, 2015
Start date
Jan 2016
Primary completion
Jun 2017
Completion
Jun 2017
Last update
Jul 2, 2017
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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