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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.
Age
22 - No limit years
Sex
ALL
Healthy Volunteers
No
Drug Research Analysis Corp
Montgomery, Alabama, United States
University of Arizona Banner - University Medical Center South Campus
Tucson, Arizona, United States
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States
University of California Davis Health
Sacramento, California, United States
University of California San Diego Health
San Diego, California, United States
Northwestern University
Evanston, Illinois, United States
Indiana University Health Hospital (Eskenazi & Methodist)
Indianapolis, Indiana, United States
Southern Clinical Research
Zachary, Louisiana, United States
University of Maryland (Baltimore & St. Joseph)
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Start Date
June 6, 2018
Primary Completion Date
October 17, 2019
Completion Date
October 17, 2019
Last Updated
March 9, 2020
3,246
ACTUAL participants
VITROS Immunodiagnostic Products
DIAGNOSTIC_TEST
Lead Sponsor
Ortho-Clinical Diagnostics, Inc.
NCT07191730
NCT07484009
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
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