To assess the additional prognostic value of combined CTP and CTA parameters to baseline patient criteria and plain CT. Secondary objective is to subsequently use the best CTP and CTA indicators of outcome of infarct in a prediction model for…
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 outcome measures will be 90 day outcome measured by modified Rankin
Scale (mRS).
Secondary outcome
Day 3 outcome (NIHSS and mRS) or earlier at discharge.
Vessel recanalization on CTA.
Final infarct size.
Asymptomatic and symptomatic hemorrhage on CT.
Background summary
Prediction of outcome is necessary to make the right therapeutic choice in
patients with acute ischemic stroke. Outcome is unpredictable on plain CT and
clinical information alone. CT perfusion and angiography are easily accessible
and can probably predict outcome and forecast the expected chance of benefit or
harm of thrombolysis or thrombectomy. This essential first step can only be
taken now before new intervention techniques are implemented.
Study objective
To assess the additional prognostic value of combined CTP and CTA parameters to
baseline patient criteria and plain CT. Secondary objective is to subsequently
use the best CTP and CTA indicators of outcome of infarct in a prediction model
for improving choice of therapy.
Study design
Prospective multi-centre cohort study.
Study burden and risks
The burden consists of an extra plain CT brain, a CT perfusion and a CT
angiography 3 days after the onset of symptoms and after 90 days a questionaire
will be performed by phone. The CT scans will take 10 minutes (30 minutes with
transport and transfer to table) and the questionaire around 15 minutes. The
risks involved are radiation and contrast reactions. Both risks are small and
acceptable considering the gravity of the deficits after a stroke. The
inclusion of incapacitated patients is justified because this is directly
related to the disease and especially this patient group is likely to benefit
from a better prediction model for therapeutic choice.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
Acute neurological deficit caused by cerebral ischemia within 9 hours of onset.
No known contraindictations against intravenous contrast.
Informed consent.
Exclusion criteria
Another diagnosis such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor.
Known contrast allergy or renal failure.
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 | NL25625.041.08 |