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

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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)

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.

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
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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171 Ashley Avenue
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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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Greenville, NC
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Houston, Texas 77030
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Idaho Falls, Idaho 83401
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Las Vegas, Nevada 89109
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Louisville, Kentucky 40202
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Louisville, KY
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Minneapolis, Minnesota 55414
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Minneapolis, MN
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Philadelphia, Pennsylvania 19107
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San Francisco, California 94110
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San Francisco, CA
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