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Sponsored by: |
Nanogen, Inc. |
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Information provided by: | Nanogen, Inc. |
ClinicalTrials.gov Identifier: | NCT00734045 |
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 |
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Congestive Heart Failure (CHF) |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples |
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 |
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1
Subjects with diagnosed congestive heart failure
|
2
Subjects not diagnosed with congestive heart failure
|
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Patients to be recruited for the study should either:
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
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 |
Congestive Heart Failure (CHF) NT-proBNP |
Heart Failure Heart Diseases |
Cardiovascular Diseases |