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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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Hoffmann-La Roche.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519961
First Posted: August 23, 2007
Last Update Posted: March 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hoffmann-La Roche
August 22, 2007
August 23, 2007
March 16, 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 ]
Not Provided
Complete list of historical versions of study NCT00519961 on ClinicalTrials.gov Archive Site
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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: None (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.
 
Unknown status
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:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Ireland,   Netherlands
Belgium,   Brazil,   Former Serbia and Montenegro,   France,   Italy,   Poland,   Serbia
 
NCT00519961
RD000485
DECREASE-VI
Not Provided
Not Provided
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Wilma Verhagen-Kamerbeek Roche Diagnostics
Hoffmann-La Roche
March 2011

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