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:
University Ghent
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
| Tracking Information | |||||
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| First Received Date ICMJE | October 30, 2006 | ||||
| Last Updated Date | December 19, 2007 | ||||
| Start Date ICMJE | August 1999 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Neuropsychological status [ Time Frame: after 6 days, 6 months and 3-5 years ] | ||||
| Original Primary Outcome Measures ICMJE |
Neuropsychological status after 6 days, 6 months and 3-5 years | ||||
| Change History | Complete list of historical versions of study NCT00394108 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Relation with intra-operative embolic load | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Changes in Cerebrovascular Reactivity During Cognitive Activation After Cardiopulmonary Bypass: Relation With Intraoperative Embolic Load and Postoperative Neuropsychological Dysfunctions | ||||
| Official Title ICMJE | Changes in Cerebrovascular Reactivity During Cognitive Activation After Cardiopulmonary Bypass: Relation With Intraoperative Embolic Load and Postoperative Neuropsychological Dysfunctions | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | CABG-Patients | ||||
| Intervention ICMJE | Procedure: Determination of neuropsychological status | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 66 | ||||
| Completion Date | July 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 69 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00394108 | ||||
| Other Study ID Numbers ICMJE | 1997/098 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Ghent | ||||
| Collaborators ICMJE | Fund for Scientific Research, Flanders, Belgium | ||||
| Investigators ICMJE |
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| Information Provided By | University Ghent | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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