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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 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
History of Changes
  Purpose

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 Intervention
Peripheral Vascular Disease
 Device: Elecsys®proBNP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Collection of 30-day and 1-year postoperative cardiac events [ Time Frame: 30-day and 1-year postoperation ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: February 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Elecsys®proBNP
Experimental: B Device: Elecsys®proBNP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 GmbH
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00519961     History of Changes
Other Study ID Numbers: RD000485, DECREASE-VI
Study First Received: August 22, 2007
Last Updated: March 15, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013