Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples (WB-13)
This study has been completed.
Sponsor:
Nanogen, Inc.
Information provided by:
Nanogen, Inc.
ClinicalTrials.gov Identifier:
NCT00734045
First received: August 11, 2008
Last updated: December 8, 2008
Last verified: December 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 June 18, 2013