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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

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ClinicalTrials.gov Identifier: NCT00519961
Recruitment Status : Unknown
Verified March 2011 by Hoffmann-La Roche.
Recruitment status was:  Recruiting
First Posted : August 23, 2007
Last Update Posted : March 16, 2011
Sponsor:
Information provided by:
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment
Peripheral Vascular Disease Device: Elecsys®proBNP

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : February 2007
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: A Device: Elecsys®proBNP
Experimental: B Device: Elecsys®proBNP



Primary Outcome Measures :
  1. Collection of 30-day and 1-year postoperative cardiac events [ Time Frame: 30-day and 1-year postoperation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519961


Contacts
Contact: Roche Diagnostics Center 1-866-805-5919 (U.S. Only) Dia_StudyInquiries@Roche.com

Locations
Ireland
Recruiting
Dublin 4, Ireland, D4
Netherlands
Recruiting
Rotterdam, Netherlands, 3000 CA
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Wilma Verhagen-Kamerbeek Roche Diagnostics

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00519961     History of Changes
Other Study ID Numbers: RD000485
DECREASE-VI
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs