Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Hoffmann-La Roche.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00519961
First received: August 22, 2007
Last updated: March 15, 2011
Last verified: March 2011

August 22, 2007
March 15, 2011
February 2007
September 2010   (final data collection date for primary outcome measure)
Collection of 30-day and 1-year postoperative cardiac events [ Time Frame: 30-day and 1-year postoperation ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00519961 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Peripheral Vascular Disease
Device: Elecsys®proBNP
  • Experimental: A
    Intervention: Device: Elecsys®proBNP
  • Experimental: B
    Intervention: Device: Elecsys®proBNP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1800
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
Both
18 Years and older
No
Contact: Roche Diagnostics Center 1-866-805-5919 (U.S. Only) Dia_StudyInquiries@Roche.com
Ireland,   Netherlands
 
NCT00519961
RD000485, DECREASE-VI
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Wilma Verhagen-Kamerbeek Roche Diagnostics GmbH
Hoffmann-La Roche
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP