CClinicalTrials.gg
Status unknownNCT00519961Updated Mar 16, 2011

A Prospective Study to Assess the Screening Value of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) for the Identification of Patients That Benefit From Additional Cardiac Testing Prior to Vascular Surgery

An interventional study of Elecsys®proBNP in Peripheral Vascular Disease, sponsored by Hoffmann-La Roche. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-16.

Sponsored by Hoffmann-La Roche · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Mar 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,800
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

This study's planned enrollment of 1,800 is above the median of 78 across 639 interventional studies indexed under Vascular Diseases.

Browse Vascular Diseases studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • N/A
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,800 participants (estimated)

Study arms

  • Experimental
    A

    Device: Elecsys®proBNP

  • Experimental
    B

    Device: Elecsys®proBNP

Interventions

  • DeviceElecsys®proBNP
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What researchers measure

Primary outcomes

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

    Time frame: 30-day and 1-year postoperation

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Study locations

2 of 2 sites recruiting
  • Dublin 4, D4, Ireland
    Recruiting
  • Rotterdam, 3000 CA, Netherlands
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00519961
Lead sponsor
Hoffmann-La Roche
First posted
Aug 23, 2007
Start date
Feb 2007
Primary completion
Sep 2010 (estimated)
Completion
Sep 2010 (estimated)
Last update
Mar 16, 2011

Study contacts

Roche Diagnostics Center
Contact
Dia_StudyInquiries@Roche.com
1-866-805-5919 (U.S. Only)
Wilma Verhagen-Kamerbeek
study director · Roche Diagnostics GmbH
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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