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

NCT ID: NCT00519961

Last Updated: 2011-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Vascular Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Elecsys®proBNP

Intervention Type DEVICE

B

Group Type EXPERIMENTAL

Elecsys®proBNP

Intervention Type DEVICE

Interventions

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Elecsys®proBNP

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Hoffmann-La Roche

Principal Investigators

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Wilma Verhagen-Kamerbeek

Role: STUDY_DIRECTOR

Roche Diagnostics GmbH

Locations

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Dublin, , Ireland

Site Status RECRUITING

Rotterdam, , Netherlands

Site Status RECRUITING

Countries

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Ireland Netherlands

Central Contacts

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Roche Diagnostics Center

Role: CONTACT

1-866-805-5919 (U.S. Only)

Other Identifiers

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DECREASE-VI

Identifier Type: -

Identifier Source: secondary_id

RD000485

Identifier Type: -

Identifier Source: org_study_id

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