Clinical Study to Validate the Use of a New Point of Care Troponin I Test
Status: | Active, not recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 4/21/2016 |
Start Date: | March 2015 |
End Date: | November 2016 |
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
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)
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.
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.
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 -
We found this trial at
14
sites
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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University of Louisville The University of Louisville is a state supported research university located in...
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Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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