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

This study has been completed.

First Received: October 30, 2006 Last Updated: December 19, 2007 History of Changes

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

Additional Information:

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

No publications provided

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

Study placed in the following topic categories:

Embolism

ClinicalTrials.gov processed this record on May 07, 2009