VITROS Immunodiagnostic Products hs Troponin I

Status unconfirmed

Conditions studied: Acute Coronary Syndrome (ACS), Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT03581578

Run by

Ortho-Clinical Diagnostics, Inc.

People needed

1630

Starts

2018-06-07

Expected to finish

2021-06-01

Last updated by the study team

2020-09-16

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subject is unable to comply with the study requirements.
• Any samples which were not obtained under IRB approved protocol.

Where it is running

• 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

Full record on ClinicalTrials.gov

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