Clinical Study to Validate the Use of a New Point of Care Troponin I Test
- Conditions
- Acute Coronary Syndrome
- Registration Number
- NCT02620397
- Lead Sponsor
- Trinity Biotech
- Brief 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)
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1500
- The informed consent must be signed by the subject, or the subject's legal authorized representative.
- 21 years of age or greater at the time of enrollment
- 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.
- Informed consent form not signed
- Age <21 years
- Known pregnancy -
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical performance of the Meritas Troponin I test 24-hours 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)
- Secondary Outcome Measures
Name Time Method Prognostic capability of sponsor's Meritas Troponin I to predict mortality (all-cause death) and cardiac events (i.e., MI, cardiac death). 1 year 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
Trial Locations
- Locations (14)
Thomas Jefferson Univeristy
🇺🇸Philadelphia, Pennsylvania, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Hennepin County Medical Ctr
🇺🇸Minneapolis, Minnesota, United States
San Francisco General Hospital & Trauma Center
🇺🇸San Francisco, California, United States
Sunrise Hospital
🇺🇸Las Vegas, Nevada, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Eastern Idaho Regional Medical Center
🇺🇸Idaho Falls, Idaho, United States
Kentucky Clinical Trials Laboratories
🇺🇸Louisville, Kentucky, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Ben Taub
🇺🇸Houston, Texas, United States