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

NCT ID: NCT02614209

Last Updated: 2016-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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In Vitro diagnostic tests

Prospective blood collection

Intervention Type DEVICE

Other Intervention Names

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Propective collection for use in InVitro diagnostic studies

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujirebio Diagnostics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diana Dickson, RAC

Role: STUDY_DIRECTOR

Fujirebio Diagnostics, Inc.

Locations

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University of Maryland

Baltimore, Maryland, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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FDI-120

Identifier Type: -

Identifier Source: org_study_id

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