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

This study has been completed.

Sponsors and Collaborators: University Ghent
Fund for Scientific Research, Flanders, Belgium
Information provided by: University Ghent
ClinicalTrials.gov Identifier: NCT00394108
  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

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

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


Website University Hospital Ghent  This link exits the ClinicalTrials.gov site
 

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

Study placed in the following topic categories:
Embolism

ClinicalTrials.gov processed this record on September 23, 2008




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