An observational study in Acute Coronary Syndrome (ACS) and Myocardial Infarction, sponsored by Ortho-Clinical Diagnostics, Inc.. Status unknown at 24 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Ortho-Clinical Diagnostics, Inc. · Observational
The purpose of this clinical study is to collect data to substantiate the use of the VITROS hs Troponin I test as an aid in the diagnosis of myocardial infarction (MI). The test is further indicated for risk stratification of mortality, myocardial infarction or coronary revascularization in patients with acute coronary syndrome.
A prospective clinical sample collection and cardiac troponin I testing will be conducted in individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS) at geographically dispersed sites in the US. Individuals who meet the inclusion/exclusion criteria, including having signed an informed consent form will be included in the study.
Clinical and laboratory data will be collected to demonstrate product performance compared to an adjudicated clinical diagnosis.
Sample collection and testing of clinical samples with the VITROS hs Troponin I test will be performed under two separate protocols.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 1,630 is above the median of 500 across 983 observational studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Ortho-Clinical Diagnostics, Inc. 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.
Individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS).
Exclusion Criteria:
Sensitivity and specificity of the VITROS hs Troponin I test
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
Time frame: VITROS hs Troponin I value at baseline
Sensitivity and specificity of the VITROS hs Troponin I test
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
Time frame: VITROS hs Troponin I value > 1 hour and up to 3 hours
Sensitivity and specificity of the VITROS hs Troponin I test
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
Time frame: VITROS hs Troponin I value at > 3 hours and up to 6 hours
Sensitivity and specificity of the VITROS hs Troponin I test
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
Time frame: VITROS hs Troponin I value at > 6 hours and up to 9 hours
Risk stratification of subjects
Assess the use of cardiac Troponin I measurement in the risk stratification of subjects.
Time frame: Up to 12 months after last enrollment
Rule in and rule out myocardial infarction (MI)
Evaluate the VITROS hs Troponin I test to rule in and rule out MI.
Time frame: VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours)
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Ortho-Clinical Diagnostics, Inc.