To investigate whether the amount of TiMas containing brain specific proteins, correlates with functional outcome and infarct size in patients with acute ischemic stroke. And, to study the kinetics of the tissue macrophages and to compare these data…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endpoints are curves of biomarker release. The association of TiMA release with
infarct size, neurological outcome and other serum markers will be inspected
with scatterplots, without statistical testing.
Secondary outcome
see above
Background summary
Stroke is a severely disabling disease. New treatments have been developed and
are being evaluated. We need biomarkers of infarct size to rapidly assess
treatment effects.
Study objective
To investigate whether the amount of TiMas containing brain specific proteins,
correlates with functional outcome and infarct size in patients with acute
ischemic stroke. And, to study the kinetics of the tissue macrophages and to
compare these data with the kinetics of plasma markers release such as NSE,
S100B, CRP, FAPB7 and FABP3, circulating histones and MPO-DNA.
Study design
This is a proof of concept study, formally an observational case series.
Study burden and risks
The burden to individual patients consists of daily bloodsampling from an IV
catheter for 5 days, carrying a small risk of cubital hematoma. Additionally,
an non-enhanced MRI will be made to assess infarct size.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
ischemic stroke onset within 6 hours
Exclusion criteria
use of immunosuppresive medication
pre stroke modified Rankin score > 2
usual contra-indications for MRI
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 | NL48968.078.14 |