Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples (WB-13)

This study has been completed.
Sponsor:
Information provided by:
Nanogen, Inc.
ClinicalTrials.gov Identifier:
NCT00734045
First received: August 11, 2008
Last updated: December 8, 2008
Last verified: December 2008

August 11, 2008
December 8, 2008
February 2008
November 2008   (final data collection date for primary outcome measure)
StatusFirst CHF NT-proBNP test result [ Time Frame: At presentation to study site (no follow-up) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00734045 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples
Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.
Congestive Heart Failure (CHF)
Not Provided
  • 1
    Subjects with diagnosed congestive heart failure
  • 2
    Subjects not diagnosed with congestive heart failure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00734045
WB-13
No
Philip Estes / Associate Director, Clinical, Nanogen
Nanogen, Inc.
Not Provided
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
Nanogen, Inc.
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP