Aim of this study is to quantify the relationship between the extent of aortic atherosclerotic disease and neurocognitive dysfunction after cardiac surgery with the use of cardiopulmonary bypass.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: The relation between atherosclerosis of the ascending aorta and
neurocognitive function at three months after surgery.
Secondary outcome
The relation between atherosclerosis of the ascending aorta and neurocognitive
function at discharge, stroke, transient ischemic attack, myocardial infarction
and renal failure.
Background summary
Cardiac surgery is associated with significant cerebral morbidity, i.e. stroke
in about 3% of patients and neurocognitive decline in up to 50% of patients.
Manipulation of an atherosclerotic ascending aorta is considered to be a major
risk-factor for the development of neurocognitive dysfunction. Several studies
have tried to establish the relation between the severity of atherosclerosis of
the ascending aorta and deterioration of cognitive function, with conflicting
results. Weaknesses in the methods used in these studies, however, make their
results difficult to interpret.
Study objective
Aim of this study is to quantify the relationship between the extent of aortic
atherosclerotic disease and neurocognitive dysfunction after cardiac surgery
with the use of cardiopulmonary bypass.
Study design
Multicenter, observational prospective cohort study.
Study burden and risks
Patient burden is minimal, it exists of testing of the neurocognitive function
at three time points (prior to surgery, at discharge and 3 months
postoperative), using a computerized test battery (CogHealth, CogState Ltd.,
Melbourne Australia). The degree of atherosclerosis of the ascending aorta
will be assessed using intraoperative epiaortic ultrasound scanning.
There are no extra risks associated with participation.
Groot Wezenland 20
8011 JW
Nederland
Groot Wezenland 20
8011 JW
Nederland
Listed location countries
Age
Inclusion criteria
A sub-sample of patients included in the diagnostic trial A-view: *Diagnostic value of an innovative non-invasive diagnostic to determine the grade of atherosclerosis before sternotomy in patients scheduled for cardiac surgery*. Patients over 65 years, undergoing sternotomy for elective cardiac surgery will be included in this study.
Exclusion criteria
Patients who undergo a re-operation or off-pump surgery, suffer from neurodegenerative disease or a known psychiatric disorder and patients who are thought to be inable to perform neurocognitive testing will be excluded from participation in the subsample.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13123.075.06 |