Extracellular vesicles (EVs) in plasma can be used as a biomarker for stroke diagnosis, thereby discriminating between ischemic and hemorrhagic stroke.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Health condition
Stroke
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome of this study is the relation between the concentration of EVs as determined in blood collected in the acute phase and the clinical diagnosis as concluded from a CT/CTA-scan. Moreover, it will be determined whether there are differences in EV concentration that can be related to either small- or large-vessel occlusion ischemic stroke.
Secondary outcome
Secondary outcomes are differences in EV concentrations between different locations of ischemic stroke. It will also be determined whether the determined concentrations can be related to detailed clinical and radiological findings other than the stroke diagnosis.
Background summary
Rationale: Stroke can be subdivided into ischemic stroke (blocked artery) or haemorrhagic stroke (ruptured artery), for which different treatment options are available. Not all therapy options are available at so called primary stroke centres – in about 25% of the cases patients need therefore to be transferred to a so-called comprehensive stroke centre (CSC). At present, computed tomography (CT-) scans are required to identify the exact cause of stroke to guide treatment. If patients have to be extra transported to CSCs to receive highly complex treatments, valuable time is lost. Ideally, the cause of stroke is diagnosed already at home or in the ambulance, so that the destination of the ambulance can be adjusted accordingly. A biomarker test which can be used very early after stroke onset is needed to guide ambulance services and patients to the best treatment facility. Objective: The main objective is to characterize extracellular vesicles (EVs) that are able to recognize the underlying cause of stroke early upon onset. For this reason, the relation between (a set of) antigens and the different types of stroke subtypes should be identified. Study population: Adult patients with a probable diagnosis of acute stroke, as made by the paramedic in the prehospital setting, will be included. A total of 750 patients will be included, at a time point where the definitive diagnosis is yet unknown. Patients that had a stroke mimic will be used as controls. Patients will be included in Amsterdam UMC, location AMC.
Study objective
Extracellular vesicles (EVs) in plasma can be used as a biomarker for stroke diagnosis, thereby discriminating between ischemic and hemorrhagic stroke.
Study design
Baseline
Age
Inclusion criteria
- - age of 18 years or older,
- - a suspicion of stroke, for whom the pre-stroke alarm is initiated by the attending paramedic and/or ER clinician,
- - written informed consent (deferred).
Exclusion criteria
- untreated coagulation abnormalities,
- (IV) treatment has started before blood collection.
Design
Recruitment
IPD sharing statement
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8961 |
| CCMO | NL72929.018.20 |
| OMON | NL-OMON52758 |