Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples

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

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-11-30

Brief Summary

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The primary objective of the study is to establish the correlation between NT-proBNP measurements in fresh human whole blood samples and those in plasma samples from the same study subjects, where said samples are collected in EDTA and Li-Hep anticoagulant tubes and measured by the StatusFirst™ CHF NT-proBNP device in conjunction with the DXpressTM Reader in a laboratory setting.

Detailed Description

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Conditions

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Congestive Heart Failure (CHF)

Keywords

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Congestive Heart Failure (CHF) NT-proBNP

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

Subjects with diagnosed congestive heart failure

No interventions assigned to this group

2

Subjects not diagnosed with congestive heart failure

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Have clinically confirmed heart failure (NYHA class I-IV) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, OR
* Be non-CHF controls greater than 45 years of age with no history of heart failure or cardiovascular disease.

Exclusion Criteria

* Be 45 years of age or younger

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Nanogen

Principal Investigators

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Alan Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California San Francisco and San Francisco General Hospital

Alan Maisel, MD

Role: PRINCIPAL_INVESTIGATOR

University of California San Diego; Veteran's Affairs

Locations

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US Department of Veteran's Affairs

San Diego, California, United States

Site Status

San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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WB-13

Identifier Type: -

Identifier Source: org_study_id