CABG-Patients Clinical Trial
Official title:
Changes in Cerebrovascular Reactivity During Cognitive Activation After Cardiopulmonary Bypass: Relation With Intraoperative Embolic Load and Postoperative Neuropsychological Dysfunctions
| Verified date | December 2007 |
| Source | University Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | July 2002 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 69 Years |
| Eligibility |
Inclusion Criteria: - CABG-patients (not urgent) - < 70 years old - Righthanded Exclusion Criteria: - Neurological or psychiatric disease - Psychoactive medication - Valve operation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Ghent | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Ghent | Fund for Scientific Research, Flanders, Belgium |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Neuropsychological status | after 6 days, 6 months and 3-5 years | ||
| Secondary | Relation with intra-operative embolic load |