VITROS Immunodiagnostic Products hs Troponin I



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:22 - Any
Updated:2/23/2019
Start Date:June 7, 2018
End Date:June 2020
Contact:Veronica Lewis
Email:veronica.lewis@orthoclinicaldiagnostics.com
Phone:908 218 8256

Use our guide to learn which trials are right for you!

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.

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.

Inclusion Criteria:

1. Subject must be ≥22 years of age at the time of consent.

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:

1. Subject is unable to comply with the study requirements.

2. Any samples which were not obtained under IRB approved protocol.
We found this trial at
19
sites
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Ava Pierce, MD
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Alexandria, Virginia 22304
Principal Investigator: Brian Krieger, MD
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Robert Christenson, Ph.D.
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Chandler, Arizona 85224
Principal Investigator: Brian R Tiffany, MD
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Gary F Headden, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Gregory Fermann, MD
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Detroit, Michigan 48201
Principal Investigator: Elizabeth Dubey, MD
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Detroit, Michigan 48202
Principal Investigator: Richard M Nowak, MD
?
mi
from
Detroit, MI
Click here to add this to my saved trials
El Paso, Texas 79905
Principal Investigator: Edward Michelson, MD
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Zubaid Rafique, MD
?
mi
from
Houston, TX
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Chad M Cannon, MD
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Milwaukee, Wisconsin 53226
Principal Investigator: Mario P Colella, DO, MPH
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
Principal Investigator: Fred Apple, PhD
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Basmah Safdar, MD
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Anna Marie Chang, MD
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Portland, Oregon 97239
Principal Investigator: Bory Kea, MD
?
mi
from
Portland, OR
Click here to add this to my saved trials
1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Principal Investigator: Christopher J Hogan, MD
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Royal Oak, Michigan 48073
Principal Investigator: Carol Clark, MD
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
Stony Brook, New York 11794
Principal Investigator: Adam J Singer, MD
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials