Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples
Completed
- Conditions
- Congestive Heart Failure (CHF)
- Registration Number
- NCT00734045
- Lead Sponsor
- Nanogen, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method StatusFirst CHF NT-proBNP test result At presentation to study site (no follow-up)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
US Department of Veteran's Affairs
🇺🇸San Diego, California, United States
San Francisco General Hospital
🇺🇸San Francisco, California, United States