The evaluate the value of the TCD in a selected patients group with a left-tailed endocarditis -treated in first case with antibiotic - to predict the chance of a CVA. The primary goal is to develop a prediction model.
ID
Source
Brief title
Condition
- Endocardial disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: development of a CVA during the hospitalization
Secondary outcome
Secondary neurological endpoints are:
1. The severity of the CVA at origin and after 3 months (NIHSS score), the type
of CVA (ischemic or hemorrhage)
2. Occurrence of TIA's,
3. Occurrence of meningitis,
4. developing a cerebral abscess/cerebritis,
5. mortality,
6. functional outcome after 3 months
7. SWI/DWI/Flair and T2 lesions on MRI brain (after 3 months or <24h prior to
surgery) in compare with inclusion MRI.
8. Occurrence of a heart surgery or valve surgery after inclusion.
Background summary
Although endocarditis is relatively rare (incidence between the
1.5-11.6/100,000 person years), the disease is still a great burden to public
health endocarditis as a disease with a high mortality and morbidity. The
mortality in an infective endocarditis is on average around the 15-20% [1.2],
rising to 80% at the presence of Staphylococcus Aureus/heart
failure/annulusabces.
Complications of endocarditis could be manifest locally in the heart itself
(abscesses/aneurysms/fistulas), but also peripheral including septic
embolization to other organs. Embolic complications, such as developing a
cerebral infarction, is associated with a greatly increased risk of mortality.
Ultrasound of the heart is not only important for the diagnosis endocarditis,
but also an important part of the risk determination to getting complications.
The risk stratification with echocardiography is not sufficiently reliable to
predict the risk of systematic and cerebral embolic complications.
Technology Doppler (TCD-Doppler) can detect micro-emboli signals (MES). This
method is shown in several studies to be effective in patients with acute
cerebral infarction, symptomatic carotid stenosis and post-operative after a
carotisendarteriƫctomy in predicting high-risk patients developing a stroke
recurrence. TCD-Doppler technology seems to be of great value in identifying a
subpopulation that, despite antibiotic therapy, is at high risk of embolic
complications.
Study objective
The evaluate the value of the TCD in a selected patients group with a
left-tailed endocarditis -treated in first case with antibiotic - to predict
the chance of a CVA. The primary goal is to develop a prediction model.
Study design
This will be a prospective, observational study with micro embolic signal
detection in patients with recently a left-tailed endocarditis diagnosis and
the treatment will be primary antibiotic.
Micro embolic signal detection with TCDx will unilaterally take place within
3-5 days after diagnosis. At inclusion and after 12 weeks is an MRI with
certain sequences (the so called diffusion weighted imaging [DWI] and the
susceptibility weighted imaging [SWI]), this makes it possible to recent
subclinical ischemic CVA's (with DWI sequences) or micro hemorrhages (with SWI
sequences). MRI will also be done with a Flair and T2 setting to not recent
ischemia to quantify. Patients who have to undergo surgery for the
endocarditis, will receive their second MRI <24hours prior to the surgery.
Study burden and risks
This study will be provide information if TCD embolism detection can be used in
risk stratification of the occurrence of a embolic CVA. There are no advantages
or disadvantages for the patient. TCD research is an easy-to-use non-invasive
analysis of the cerebral blood stream by ultra sound.
Els Borst-Eilersplein 275
Den Haag 2545AA
NL
Els Borst-Eilersplein 275
Den Haag 2545AA
NL
Listed location countries
Age
Inclusion criteria
1. Proven left-tailed infective native endocarditis or bioprosthetic valves
endocarditis
2. ultrasound test of the heart not older than 2 weeks
3. 18 years and older
4. mentally competent
5. written informed consent
Exclusion criteria
1. right-tailed endocarditis
2. left-tailed endocarditis with already an emergency indication for
heartsurgery/valve replacement (<24h)
3. lack of a temporal window
4. severe claustrophobia or other MRI contraindications
5. Clinical manifistations of an old/recent CVA
6. mechanical valve
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL66257.098.18 |