Clinical Study to Validate the Use of a New Point of Care Troponin I Test

N/AUnknownNCT02620397

Trinity Biotech1,500 enrolled

Overview

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)

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.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Acute Coronary Syndrome

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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 -

Locations (14)

San Francisco General Hospital & Trauma Center

San Francisco, California, United States

University of Florida

Gainesville, Florida, United States

Eastern Idaho Regional Medical Center

Outcomes

Primary Outcomes

Clinical performance of the Meritas Troponin I test

Clinical performance indicators (Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) and their respective 95 % confidence intervals (CIs) will be calculated for the quantitative determination of cardiac troponin I (cTnI) for use as an aid in the diagnosis of myocardial infarction (MI)

Time frame: 24-hours

Secondary Outcomes

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

Kaplan-Meier survival curves and risk ratios. A multivariate Cox proportional model with known risk factors as covariates in addition to the Troponin test result will be included in the data analysis

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.