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

Sponsored by:	Nanogen, Inc.
Information provided by:	Nanogen, Inc.
ClinicalTrials.gov Identifier:	NCT00734045

Purpose

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.

Condition
Congestive Heart Failure (CHF)

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples

Further study details as provided by Nanogen, Inc.:

Primary Outcome Measures:

StatusFirst CHF NT-proBNP test result [ Time Frame: At presentation to study site (no follow-up) ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:	450
Study Start Date:	February 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Subjects with diagnosed congestive heart failure
2 Subjects not diagnosed with congestive heart failure

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients to be recruited for the study should either:

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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734045

Locations

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
US Department of Veteran's Affairs
San Diego, California, United States, 92161

Sponsors and Collaborators

Nanogen, Inc.

Investigators

Principal Investigator:	Alan Wu, PhD	University of California San Francisco and San Francisco General Hospital
Principal Investigator:	Alan Maisel, MD	University of California San Diego; Veteran's Affairs

More Information

Responsible Party:	Nanogen ( Philip Estes / Associate Director, Clinical )
Study ID Numbers:	WB-13
Study First Received:	August 11, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00734045
Health Authority:	United States: Institutional Review Board

Keywords provided by Nanogen, Inc.:

Congestive Heart Failure (CHF)
NT-proBNP

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009