Clinical Performance Evaluation of AQT90 FLEX TnI and TnT

NCT02624024 | Completed

• 1 other identifier: DC-059975
• Study Type: observational
• Target: 1,743
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Myocardial Infarction

Outcome Measures

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.

  during the first 24 hours after presentation to the emergency department

Study Arms (1)

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)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• Subject is pregnant or may be pregnant.
• Subject has an invalid written informed consent or has withdrawn consent.

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Sites (8)

Honor Health Scottsdale Osborn Medical Center

Scottsdale, Arizona, 85251, United States

Location

Honor Health Scottsdale Shea Medical Center

Scottsdale, Arizona, 85258, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Indiana University Health Ball Memorial Hospital

Muncie, Indiana, 47303, United States

Location

UMASS Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University of Cincinnati Department of Emergency Medicine

Cincinnati, Ohio, 45267, United States

Location

Catholic Health Initiatives Institute for Research and Innovation -CHI Franciscan Health

Tacoma, Washington, 98405, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen plasma samples are retained for this study and possible future studies.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 8, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

US (8)