Background
Methods/design
Design
Study Phase | Tasks | 2023 | 2024 | 2025 | 2026 | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
quarter (proposed trial duration) | |||||||||||||||||
Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | ||
Execution | Screening and inclusion period | ||||||||||||||||
3 months follow-up | |||||||||||||||||
possible extended Follow-Up | |||||||||||||||||
Analysis | Final data analysis | ||||||||||||||||
preparataion of manuscript |
Patient population – inclusion and exclusion criteria
Inclusion criteria
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Juvenile stroke patients aged 18–55 years and older stroke patients > 55 years, both patients with first-ever strokes as well as with recurrent events can be enrolled
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Written informed consent by the patient or their legal representatives obtained at the latest prior to the 3 months follow-up
Exclusion criteria
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The patient is directly involved in the conduct of the protocol
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Refusal of consent
Treatment or intervention
Primary outcomes
Secondary outcomes
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Preadmission factors (age, CHA2DS2-VASc-Score)
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Clinical, imaging and laboratory findings at admission (National Institutes of Health Stroke Scale (NIHSS), Alberta stroke programme early CT score (ASPECTS), glucose level))
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Results of diagnostic investigations during the in-hospital stay (mean intima-media thickness on ultrasonography, underlying aetiology)
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treatment given at admission or discharge (intravenous thrombolysis, reperfusion success measured by the modified Thrombolysis in Cerebral Infarction (mTICI) score, antithrombotic therapy given at discharge)
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Demographic data (gender, ethnicity)
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Medical/surgical history (pre-existing illnesses/previous operations, cardiovascular risk factors, signs and symptoms, onset of symptoms, premorbid mRS)
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Relevant concomitant treatment (type of therapy, name of medication, daily dosage and duration for such use)
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family history (positive family history defined as cardiovacular event in a first-degree relative < 65 years)
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Neurological examination (NIHSS after 24 hours as well as at discharge)
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Vital signs (blood pressure, heart rate, oxygen saturation, blood glucose)
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Patient-reported outcome measures (clinical global impression)
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Medical/surgical history (new illnesses, operations that have taken place during the interval, cardiovascular risk factors, current signs and symptoms, mRS)
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Relevant medication (type of therapy, name of medication, daily dosage and duration for such use)
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Patient-reported outcome measures (clinical global impression, EuroQol – Visual analogue scale)
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Questionnaires on quality of life and depression (Beck-Depression-Inventory, EuroQol 5 dimensions with 5 response levels)
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Cognitive assessment (Montreal Cognitive Assessment (MoCA))
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Neurological examination (NIHSS)
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Vital signs
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Electrocardiogram
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Laboratory analyses
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Neuroimaging (cerebral CT/CT angiography, CT perfusion, MRI, MR angiography)
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Digital subtraction angiography (DSA)
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Additional imaging modalities (e.g., X-ray, positron emission tomography)
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Doppler/duplex sonography
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Electroencephalography
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Transthoracic echocardiography/ transoesophageal echocardiography
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Long-term electrocardiogram
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Cancer screening (e.g. X-ray, CT-thorax/abdomen, gynecologic/dermatologic examination)
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Loop-recorder implantation
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Questionnaires
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CSF analysis
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Additional laboratory analyses