Clinical Performance Evaluation of AQT90 FLEX TnI and TnT

Myocardial Infarction Clinical Trial

Official title:

AQT90 FLEX TnI and TnT - Clinical Sensitivity and Specificity Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624024
• Other study ID #: DC-059975
• Status: Completed
• Phase: N/A
• First received: December 4, 2015
• Last updated: June 30, 2017
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Radiometer Medical ApS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1743
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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• Subject has an invalid written informed consent or has withdrawn consent.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Cincinnati Department of Emergency Medicine	Cincinnati	Ohio
United States	Indiana University Health Ball Memorial Hospital	Muncie	Indiana
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Honor Health Scottsdale Osborn Medical Center	Scottsdale	Arizona
United States	Honor Health Scottsdale Shea Medical Center	Scottsdale	Arizona
United States	Catholic Health Initiatives Institute for Research and Innovation -CHI Franciscan Health	Tacoma	Washington
United States	UMASS Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Radiometer Medical ApS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	during the first 24 hours after presentation to the emergency department