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

December 8, 2008 updated by: Nanogen, Inc.
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Subjects with diagnosed congestive heart failure
2
Subjects not diagnosed with congestive heart failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
StatusFirst CHF NT-proBNP test result
Time Frame: At presentation to study site (no follow-up)
At presentation to study site (no follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimate)

August 13, 2008

Study Record Updates

Last Update Posted (Estimate)

December 10, 2008

Last Update Submitted That Met QC Criteria

December 8, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WB-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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