Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1630 participants
OBSERVATIONAL
2018-06-07
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Subject presenting with symptoms suggestive of acute coronary syndrome including chest pain, or chest pain equivalent.
3. Must have an Electrocardiogram (ECG) ordered as part of the subject's standard of care.
4. Subject willing and able to provide informed consent.
Exclusion Criteria
2. Any samples which were not obtained under IRB approved protocol.
22 Years
ALL
No
Sponsors
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Ortho-Clinical Diagnostics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Fred Apple, PhD
Role: PRINCIPAL_INVESTIGATOR
Hennepin Healthcare Research Institute
Richard Nowak, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Locations
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Drug Research and Analysis Corp
Montgomery, Alabama, United States
Chandler Regional Medical Center
Chandler, Arizona, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Mass General Hospital
Boston, Massachusetts, United States
Wayne State University/Detroit Receiving Hospital
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Beaumont
Royal Oak, Michigan, United States
Hennepin County Medical Center/Minneapolis Medical Research Foundation
Minneapolis, Minnesota, United States
Cooper University Hospital
Camden, New Jersey, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oregon Health Science University Hospital
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, United States
Ben Taub General Hospital / Baylor College of Medicine/Harris Health System
Houston, Texas, United States
INOVA Alexandria Hospital
Alexandria, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Medical College of Wisconsin and Froedtert Hospital
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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16-002
Identifier Type: -
Identifier Source: org_study_id
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