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
  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)

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

Resource links provided by NLM:


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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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

Keywords provided by Nanogen, Inc.:
Congestive Heart Failure (CHF)
NT-proBNP

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014