NCT00394108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 1999

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2006

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

October 30, 2006

Last Update Submit

December 19, 2007

Conditions

CABG-Patients

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological status

    after 6 days, 6 months and 3-5 years

Secondary Outcomes (1)

  • Relation with intra-operative embolic load

Interventions

Determination of neuropsychological statusPROCEDURE

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Neurological or psychiatric disease
  • Psychoactive medication
  • Valve operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

Study Officials

  • Guy Vingerhoets, Psychologist

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2006

First Posted

October 31, 2006

Study Start

August 1, 1999

Study Completion

July 1, 2002

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

BE(1)