Overview

This trial is active, not recruiting.

Condition acute coronary syndrome
Sponsor Trinity Biotech
Start date March 2015
End date October 2015
Trial size 1500 participants
Trial identifier NCT02620397, CP7001_5ACS

Summary

This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating emergency departments with symptoms suggestive of acute coronary syndrome (ACS)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
Clinical performance of the Meritas Troponin I test
time frame: 24-hours

Secondary Outcomes

Measure
Prognostic capability of sponsor's Meritas Troponin I to predict mortality (all-cause death) and cardiac events (i.e., MI, cardiac death).
time frame: 1 year

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: 1. The informed consent must be signed by the subject, or the subject's legal authorized representative. 2. 21 years of age or greater at the time of enrollment 3. Subjects presenting to the ED with any symptoms suggestive of ACS and/or myocardial ischemia, such as but not limited to: subjects currently having chest pain, pressure or a burning sensation across the precordium and epigastrium, pain that radiates to neck, shoulder, jaw, back, upper abdomen and either arm. Exclusion Criteria: 1. Informed consent form not signed 2. Age <21 years 3. Known pregnancy -

Additional Information

Official title Clinical Study to Validate the Use of a New Point of Care Troponin I Test as an Aid in the Diagnosis of Myocardial Infarction and Prognosis of Subjects Presenting With Symptoms of Acute Coronary Syndrome
Description This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating Emergency Departments (EDs) with symptoms suggestive of ACS and/or myocardial ischemia. Subjects presenting with symptoms suggestive of ACS will be screened and approached for consent for study enrollment by trained personnel. After obtaining written informed consent, subjects will have up to 4 blood samples collected for cTnI testing using the Meritas Troponin I test and Meritas point-of-care (POC) Analyzer. Blood draws and testing will occur at 4 intervals over 24 hours.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Trinity Biotech.