Detection of High Intensity Transient Signals as hemodynamic parameter in patients undergoing aortic valve replacement
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Detection of HITS after aortic valve replacement with determination of the
accuracy and precision of the diagnostic test.
Secondary outcome
- Optimum orientation of mechanical valves
- Origin and nature (pathogenesis)of HITS
- Postoperative depravation of H.I.T.S.
- Difference between HITS measurement in mechanical and biological valve
prosthesis
Background summary
Aortic valve replacement increases the risk of trombo embolic events. By
replacing the aortic valve with either mechanical valve prosthesis or a
biological valve prosthesis there are a lot of anatomical and biomechanical
changes that can cause micro-emboli. These micro-emboli can be detected with
transcranial Doppler ultrasonography (TCD). The detected signals either from
gaseous, fluid or solid emboli are so called High Intensity Transient Signals
(HITS). The hypothesis is that during and after aortic valve replacement a lot
of micro-emboli are coming in existence of circulation and contribute to
cognitive deficits and psychoneurological dysfunction.
Study objective
Detection of High Intensity Transient Signals as hemodynamic parameter in
patients undergoing aortic valve replacement
Study design
Observational Study
Study burden and risks
The transcranial Doppler ultrasonography is a non-invasive diagnostic tool with
negligible risks. The burden for the patients consists of participating in a 30
to 45 minutes during TCD and participate in 4 neurocognitive tests
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
- All patients undergoing isolated aortic valve replacement
- Replacement for acquired aortic valve disease
- INR in therapeutic range when measuring HITS
Exclusion criteria
- Concomitant procedures
- Congential lesions
- No sinus rhytm
- Carotic artery diseases
- History of cerebrovascular events (stroke as well as transient ischemic attack)
- Neurocognitive deficits and psychiatric disorder
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 | NL16367.060.07 |