Back to resultsA 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
Primary Purpose
Peripheral Vascular Disease
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Elecsys®proBNP
Sponsored by
About this trial
This is an interventional diagnostic trial for Peripheral Vascular Disease
Eligibility Criteria
Inclusion Criteria:
- Adult patients, ≥18 years of age
- Patients with peripheral vascular atherosclerosis, scheduled for vascular surgery
Exclusion Criteria:
- N/A
Sites / Locations
- Recruiting
- Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Collection of 30-day and 1-year postoperative cardiac events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00519961
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Elecsys®proBNP
Primary Outcome Measure Information:
Title
Collection of 30-day and 1-year postoperative cardiac events
Time Frame
30-day and 1-year postoperation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, ≥18 years of age
Patients with peripheral vascular atherosclerosis, scheduled for vascular surgery
Exclusion Criteria:
N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roche Diagnostics Center
Phone
1-866-805-5919 (U.S. Only)
Email
Dia_StudyInquiries@Roche.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilma Verhagen-Kamerbeek
Organizational Affiliation
Roche Diagnostics
Official's Role
Study Director
Facility Information:
City
Dublin 4
ZIP/Postal Code
D4
Country
Ireland
Individual Site Status
Recruiting
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
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
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