NCT00519961

Brief Summary

The purpose of this study is to validate the screening potential of NT-proBNP for the identification of patients scheduled for vascular surgery who would benefit from additional pre-operative cardiac testing. All patients will have NT-proBNP concentrations measured pre-operatively. For low-intermediate risk patients only those with abnormal values will receive further cardiac testing; all high risk patients will be referred for additional testing.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2007

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

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

February 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

Enrollment Period

3.6 years

First QC Date

August 22, 2007

Last Update Submit

March 15, 2011

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

  • Collection of 30-day and 1-year postoperative cardiac events

    30-day and 1-year postoperation

Study Arms (2)

A

EXPERIMENTAL
Device: Elecsys®proBNP

B

EXPERIMENTAL
Device: Elecsys®proBNP

Interventions

Elecsys®proBNPDEVICE
AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients, \≥18 years of age
  • Patients with peripheral vascular atherosclerosis, scheduled for vascular surgery

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Dublin, D4, Ireland

RECRUITING

Unknown Facility

Rotterdam, 3000 CA, Netherlands

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Wilma Verhagen-Kamerbeek

    Roche Diagnostics GmbH

    STUDY DIRECTOR

Central Study Contacts

Roche Diagnostics Center

CONTACT

1-866-805-5919 (U.S. Only)Dia_StudyInquiries@Roche.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 23, 2007

Study Start

February 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

March 16, 2011

Record last verified: 2011-03

Locations

NL(1)IE(1)