VITROS Immunodiagnostic Products hs Troponin I
- Conditions
- Acute Coronary Syndrome (ACS)Myocardial Infarction
- Registration Number
- NCT03581578
- Lead Sponsor
- Ortho-Clinical Diagnostics, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1630
- Subject must be ≥22 years of age at the time of consent.
- Subject presenting with symptoms suggestive of acute coronary syndrome including chest pain, or chest pain equivalent.
- Must have an Electrocardiogram (ECG) ordered as part of the subject's standard of care.
- Subject willing and able to provide informed consent.
- Subject is unable to comply with the study requirements.
- Any samples which were not obtained under IRB approved protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of the VITROS hs Troponin I test VITROS hs Troponin I value at > 6 hours and up to 9 hours Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
- Secondary Outcome Measures
Name Time Method Rule in and rule out myocardial infarction (MI) VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours) Evaluate the VITROS hs Troponin I test to rule in and rule out MI.
Risk stratification of subjects Up to 12 months after last enrollment Assess the use of cardiac Troponin I measurement in the risk stratification of subjects.
Trial Locations
- Locations (24)
Mass General Hospital
🇺🇸Boston, Massachusetts, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Ben Taub General Hospital / Baylor College of Medicine/Harris Health System
🇺🇸Houston, Texas, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Beaumont
🇺🇸Royal Oak, Michigan, United States
Hennepin County Medical Center/Minneapolis Medical Research Foundation
🇺🇸Minneapolis, Minnesota, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Texas Tech University Health Sciences Center El Paso
🇺🇸El Paso, Texas, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Drug Research and Analysis Corp
🇺🇸Montgomery, Alabama, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health Science University Hospital
🇺🇸Portland, Oregon, United States
Chandler Regional Medical Center
🇺🇸Chandler, Arizona, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Wayne State University/Detroit Receiving Hospital
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
INOVA Alexandria Hospital
🇺🇸Alexandria, Virginia, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Medical College of Wisconsin and Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States