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NCT00734045 Clinical Trial

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

Congestive Heart Failure (CHF) Clinical Trial

— WB-13  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00734045
Other study ID # WB-13
Secondary ID
Status Completed
Phase N/A
First received August 11, 2008
Last updated December 8, 2008
Start date February 2008
Est. completion date November 2008

Study information
Verified date December 2008
Source Nanogen, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 45 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States US Department of Veteran's Affairs San Diego California
United States San Francisco General Hospital San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Nanogen, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary StatusFirst CHF NT-proBNP test result At presentation to study site (no follow-up) No
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