Clinical Study to Validate the Use of a New Point of Care Troponin I Test
This trial is active, not recruiting.
|Condition||acute coronary syndrome|
|Start date||March 2015|
|End date||October 2015|
|Trial size||1500 participants|
|Trial identifier||NCT02620397, CP7001_5ACS|
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)
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|San Francisco, CA||San Francisco General Hospital & Trauma Center||no longer recruiting|
|Gainesville, FL||University of Florida||no longer recruiting|
|Idaho Falls, ID||Eastern Idaho Regional Medical Center||no longer recruiting|
|Louisville, KY||Kentucky Clinical Trials Laboratories||no longer recruiting|
|Louisville, KY||University of Louisville||no longer recruiting|
|Baltimore, MD||University of Maryland||no longer recruiting|
|Minneapolis, MN||Hennepin County Medical Ctr||no longer recruiting|
|Las Vegas, NV||Sunrise Hospital||no longer recruiting|
|Charlotte, NC||Carolinas Medical Center||no longer recruiting|
|Greenville, NC||East Carolina University||no longer recruiting|
|Philadelphia, PA||Thomas Jefferson Univeristy||no longer recruiting|
|Charleston, SC||Medical University of South Carolina||no longer recruiting|
|Nashville, TN||Vanderbilt University||no longer recruiting|
|Houston, TX||Ben Taub||no longer recruiting|
Clinical performance of the Meritas Troponin I test
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).
time frame: 1 year
Male or female participants at least 21 years old.
- 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 -
|Official title||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|
|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.|
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