Specimens With BNP Values of 5 to 5000 pg/mlABCNCT01434433
Alere Triage fs B-type Natriuretic Peptide (BNP) Method Comparison Evaluation
An observational study of Specimens With BNP Values of 5 to 5000 pg/ml and Triage, run by Alere San Diego.
Trial summary
This study will evaluate method correlation and mean bias between six B-type natriuretic peptide (BNP) platforms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Specimens With BNP Values of 5 to 5000 pg/ml, Triage
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency Department, Hospital
Who may be able to join
- Samples with BNP range of 5-5000 pg/ml
- Samples with sufficient volume for testing
Who cannot join
- BNP <5 pg/ml
About this study
Official title: Alere Triage fs BNP Method Comparison Evaluation
This study will evaluate method correlation and mean bias between six B-type natriuretic peptide (BNP) platforms.
What is being measured
The primary outcome is the main question the study is designed to answer.
bias
Measured: Sept 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specimens With BNP Values of 5 to 5000 pg/mlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alere San Diego
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred Apple, M.D., Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434433
- Sponsor's protocol ID
- BSTE-9012
- Acronym
- ABC
- Status last verified
- Dec 2023
- First submitted
- 13 Sep 2011
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alere Triage fs BNP Method Comparison Evaluation
- ClinicalTrials.gov ID
- NCT01434433
- Acronym / sponsor ID
- ABC / BSTE-9012
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Alere San DiegoIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate method correlation and mean bias between six B-type natriuretic peptide (BNP) platforms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency Department, Hospital
Key inclusion criteria (2 listed)
- Samples with BNP range of 5-5000 pg/ml
- Samples with sufficient volume for testing
Key exclusion criteria (1 listed)
- BNP <5 pg/ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
bias
Time frame: Sept 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Apple, M.D. principal investigator
Hennepin Healthcare Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Specimens With BNP Values of 5 to 5000 pg/ml and Triage, run by Alere San Diego.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bias (time frame: Sept 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.