Blood Collection of Patient Presenting in the ED and Prescribed a BNP (BNP)

August 9, 2016 updated by: Fujirebio Diagnostics, Inc.

A Blood Collection From Patients Presenting in the Emergency Department and Prescribed a Brain Natriuretic Peptide (BNP) Laboratory Test

Plasma specimen collected from patients presenting in the Emergency Department (ED) with or without Heart Failure (HF) and prescribed a BNP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Plasma samples are collected from a minimum of 400 subjects. Specimens are used to confirm the currently accepted BNP cut off as and aid in the diagnosis and assessment of HF.

Stored specimens for future use in BNP assay development.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to ED and prescribed a BNP with or without HF

Description

Inclusion Criteria:

  • Males and females >21 years of age
  • Able to understand and willing to provide informed consent
  • Present in to ED
  • BNP test requested

Exclusion Criteria:

  • Males and females< 21 years
  • Unable to provide informed consent
  • Not presenting to ED
  • hemolyzed sample

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure BNP
Time Frame: 6 months
400 subjects
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujirebio Diagnostics, Inc.

Investigators

  • Study Director: Diana Dickson, RAC, Fujirebio Diagnostics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDI-120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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