An observational study in Acute Coronary Syndrome, sponsored by Trinity Biotech. Status unknown at 14 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2015-12-15.
Sponsored by Trinity Biotech · Observational
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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Trinity Biotech is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Approximately 1000 to 1500 adult subjects presenting to emergency departments (ED) with symptoms suggestive of acute coronary sydrome (ACS) and/or myocardial ischemia
Exclusion Criteria:
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
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
This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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