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

Peripheral Vascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00519961
• Other study ID #: RD000485
• Secondary ID: DECREASE-VI
• Status: Recruiting
• Phase: N/A
• First received: August 22, 2007
• Last updated: March 15, 2011
• Start date: February 2007
• Est. completion date: September 2010

Study information

• Verified date: March 2011
• Source: Hoffmann-La Roche
• Contact: Roche Diagnostics Center
• Phone: 1-866-805-5919 (U.S. Only)
• Email: Dia_StudyInquiries[@]Roche.com
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, ≥18 years of age

• Patients with peripheral vascular atherosclerosis, scheduled for vascular surgery

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Elecsys®proBNP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Ireland,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of 30-day and 1-year postoperative cardiac events		30-day and 1-year postoperation	No