Changes in Cerebrovascular Reactivity During Cognitive Activation After Cardiopulmonary Bypass: Relation With Intraoperative Embolic Load and Postoperative Neuropsychological Dysfunctions

This study has been completed.
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT00394108
First received: October 30, 2006
Last updated: December 19, 2007
Last verified: December 2007
  Purpose

The study aims to evaluate neuropsychological disorders in CABG patients. Measurements are performed 1 day before, 6 days, 6 months and 3-5 years after the surgery. The relation with cerebrovascular reactivity and embolic load (measured by transcranial Doppler Ultrasonography) is evaluated. Two surgery techniques (on- and off-pump CABG) are compared.


Condition Intervention
CABG-Patients
Procedure: Determination of neuropsychological status

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Changes in Cerebrovascular Reactivity During Cognitive Activation After Cardiopulmonary Bypass: Relation With Intraoperative Embolic Load and Postoperative Neuropsychological Dysfunctions

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Neuropsychological status [ Time Frame: after 6 days, 6 months and 3-5 years ]

Secondary Outcome Measures:
  • Relation with intra-operative embolic load

Enrollment: 66
Study Start Date: August 1999
Study Completion Date: July 2002
  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CABG-patients (not urgent)
  • < 70 years old
  • Righthanded

Exclusion Criteria:

  • Neurological or psychiatric disease
  • Psychoactive medication
  • Valve operation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00394108

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Fund for Scientific Research, Flanders, Belgium
Investigators
Principal Investigator: Guy Vingerhoets, Psychologist University Hospital, Ghent
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00394108     History of Changes
Other Study ID Numbers: 1997/098
Study First Received: October 30, 2006
Last Updated: December 19, 2007
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on July 29, 2014