Clinical Performance Evaluation of AQT90 FLEX TnI and TnT

June 30, 2017 updated by: Radiometer Medical ApS

AQT90 FLEX TnI and TnT - Clinical Sensitivity and Specificity Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1743

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the first 24 hours after presentation to the emergency department

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiometer Medical ApS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 8, 2015

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC-059975

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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