NT-proBNP for Evaluation of the Dyspneic Patient in the E... | NCT00271128

Studies
NT-proBNP for Evaluation of the Dyspneic Patient in the Emergency Room and the Medical Ward

NCT00271128

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Mar 20, 2008Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Shortness of Breath
Acute Exacerbation

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Not provided

Completion Date

Sep 2007Estimated

First Submitted Date

Dec 29, 2005

First Submission Date that Met QC Criteria

Dec 29, 2005

First Posted Date

Dec 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2008

Last Update Posted Date

Mar 20, 2008Estimated

Description Module

Brief Summary

The proposed study intends to evaluate the impact of the NT-proBNP assay on the diagnosis of heart failure in patients with dyspnea of unknown etiology presenting to the emergency room and admitted to the medical wards.

Detailed Description

Patients will be consented and randomized to open or blinded NT-proBNP test performed within 90 minutes in a venous blood sample.

Evaluation of the ER diagnosis and final discharge diagnosis in admitted patients will be carried out in light of the NT-proBNP results.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute shortness of breath of unknown etiology as presentation to the emergency room
Possible acute exacerbation of known heart failure

Exclusion Criteria:

None -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Simcha R Meisel, MD MSc	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24062895	Derived	Meisel SR, Januzzi JL, Medvedovski M, Sharist M, Shochat M, Ashkar J, Peschansky P, Haim SB, Blondheim DS, Glikson M, Shotan A. Pre-admission NT-proBNP improves diagnostic yield and risk stratification - the NT-proBNP for EValuation of dyspnoeic patients in the Emergency Room and hospital (BNP4EVER) study. Eur Heart J Acute Cardiovasc Care. 2012 Jun;1(2):99-108. doi: 10.1177/2048872612447049.

ID	Term
D004417	Dyspnea
D006333	Heart Failure

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms