NCT00587938

Brief Summary

Measurement of brain natriuretic peptide (BNP) in dyspneic patients increases diagnostic accuracy for congestive heart failure (CHF). Limited information is available regarding economic outcomes attributable to BNP assay. The aim of this study was to assess the economic impact of BNP assay in elderly dyspneic patients presenting to the emergency department (ED).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
Last Updated

January 8, 2008

Status Verified

December 1, 2007

Enrollment Period

1.2 years

First QC Date

December 26, 2007

Last Update Submit

December 26, 2007

Conditions

Keywords

congestive heart failureBrain naturietic peptidehospital utilization cost

Outcome Measures

Primary Outcomes (1)

  • Mean total hospital cost per subject

    spans from ED eval through hospitalization discharge

Secondary Outcomes (1)

  • Included admission rate, service assignment, discharge diagnosis, and length of stay.

    from ED evaluation through hospitalization discharge

Study Arms (2)

A

BNP level from protocol blood tests initiated in the ED, reported to ED physician prior to ED disposition.

B

BNP level from protocol blood tests initiated in the ED, NOT reported to ED physician prior to ED disposition.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Dyspneic patients:65 years or older presenting to the ED with chief complaint of shortness of breath, were enrolled in a randomized, controlled trial.

You may qualify if:

  • Dyspneic patients 65 years or older presenting to the ED with chief complaint of shortness of breath.

You may not qualify if:

  • hemodynamically unstability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Marys Hospital, Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • Schmidt TA, Salo D, Hughes JA, Abbott JT, Geiderman JM, Johnson CX, McClure KB, McKay MP, Razzak JA, Schears RM, Solomon RC; SAEM Ethics Committee. Confronting the ethical challenges to informed consent in emergency medicine research. Acad Emerg Med. 2004 Oct;11(10):1082-9. doi: 10.1197/j.aem.2004.05.028.

    PMID: 15466152BACKGROUND
  • Clavell AL, Stingo AJ, Aarhus LL, Burnett JC Jr. Biological actions of brain natriuretic peptide in thoracic inferior vena caval constriction. Am J Physiol. 1993 Dec;265(6 Pt 2):R1416-22. doi: 10.1152/ajpregu.1993.265.6.R1416.

    PMID: 8285286BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Original protocol specifies a single 10 ml of blood is collected and frozen from each study participant (N=200), to be available for research assays.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Raquel M Schears, MD, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
  • Alfredo L Clavell, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
  • Lyle J Olsen, MD

    Mayo Clinic

    STUDY CHAIR
  • Paula J Santrach, MD

    Mayo Clinic

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 8, 2008

Study Start

December 1, 2003

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

January 8, 2008

Record last verified: 2007-12

Locations