VITROS Immunodiagnostic Products NT-proBNP II



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:22 - Any
Updated:2/23/2019
Start Date:June 6, 2018
End Date:August 2019
Contact:Stacey Alvey, MT(ASCP)SBB
Email:stacey.alvey@orthoclinicaldiagnostics.com
Phone:908-704-3108

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Amino Terminal pro-Brain Natriuretic Peptide (NTproBNP) is secreted in conditions of cardiac
wall stress. NTproBNP levels are used in addition to clinical assessment to diagnose heart
failure (HF). The purpose of this clinical study is to collect data to substantiate the use
of the VITROS NT-proBNP II assay.

A prospective clinical sample collection and NT-proBNP testing will be conducted in two
populations. Patients presenting to the Emergency Department (ED) and patients presenting to
outpatient centers will be approached for enrollment.

Clinical and laboratory data will be collected to demonstrate product performance compared to
adjudicated clinical diagnosis. Approximately 4300 evaluable subjects at geographically
dispersed sites in the US will be enrolled in the study.

Sample collection and testing of clinical samples with the VITROS NT-proBNP II assay will be
performed under two separate protocols.

Acute HF Population (ED setting):

Inclusion Criteria:

- Subjects must have suspicion of HF and acute symptoms at presentation.

- Subjects must be at least 22 years of age.

- Subjects must be willing and able to provide informed consent.

Exclusion Criteria:

- Acute symptoms clearly not secondary to HF.

- Subjects with renal disease on dialysis.

- Subjects unable to comply with the study requirements.

Population with suspicion of HF (Outpatient Setting):

Inclusion Criteria:

- Subjects must be at least 22 years of age.

- Subjects must be willing and able to provide informed consent.

- Subjects who present to outpatient centers with suspicion HF.

Exclusion Criteria:

- Symptoms clearly not secondary to HF.

- Subjects with renal disease on dialysis.

- Subjects unable to comply with the study requirements.

- Subjects previously diagnosed with heart failure.
We found this trial at
25
sites
Detroit, Michigan 48202
Principal Investigator: Gillian Grafton, DO
Phone: 313-829-3570
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Hanna K Gaggin, MD
Phone: 703-618-0176
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: James Tauras, MD
Phone: 718-904-2067
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Brian Bales, MD
Phone: 615-936-8024
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Baltimore, Maryland 21201
Principal Investigator: Robert Christenson, MD
Phone: 443-527-3861
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Baltimore, MD
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Beverly Hills, California 90211
Principal Investigator: Norman Lepor, MD
Phone: 310-289-5221
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Beverly Hills, CA
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Charlotte, North Carolina 28203
Principal Investigator: Michael Runyon, MD
Phone: 704-355-3841
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Charlotte, NC
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Cincinnati, Ohio 45267
Principal Investigator: Gregory Fermann, MD
Phone: 513-558-6405
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Cincinnati, OH
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Sharon Mace, MD
Phone: 216-444-0231
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Deborah Diercks, MD
Phone: 214-648-2767
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Detroit, Michigan 48202
Principal Investigator: Arun Kumar, MD
Phone: 313-745-4238
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Detroit, MI
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Evanston, Illinois 60208
Principal Investigator: Daniel M Courtney, MD
Phone: 312-926-8117
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Evanston, IL
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Falls Church, Virginia 22042
Principal Investigator: Henry Tran, MD
Phone: 703-776-7877
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Houston, Texas 77030
Principal Investigator: Zubaid Rafique, MD
Phone: 713-873-7042
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Indianapolis, Indiana 46202
Principal Investigator: Peter Pang, MD
Phone: 317-962-5024
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Las Vegas, Nevada 89121
Principal Investigator: Roger Estevez, MD
Phone: 702-570-6107
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Montgomery, Alabama 36106
Principal Investigator: Steven G O'Mara, MD
Phone: 334-265-2700
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Montgomery, AL
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: AnnaMarie Chang, MD
Phone: 215-955-2471
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Royal Oak, Michigan 48073
Principal Investigator: Carol Clark, MD
Phone: 248-898-1792
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Royal Oak, MI
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2315 Stockton Boulevard
Sacramento, California 95817
Principal Investigator: Lisa Mills, MD
Phone: 916-734-8131
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San Antonio, Texas 78215
Principal Investigator: David Grant, MD
Phone: 210-227-1289
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San Diego, California 92093
Principal Investigator: Lori Daniels, MD
Phone: 541-610-2770
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Tucson, Arizona 85724
Principal Investigator: Kwan Lee, MD
Phone: 520-626-2471
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Simon Mahler, MD
Phone: 336-716-2044
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Zachary, Louisiana 70791
Principal Investigator: Ernest G Thompson, Jr, MD
Phone: 225-654-9901
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Zachary, LA
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