Cerebral amyloid angiopathy fluid biomarkers evaluation (CAFE) - CAFE

Radboud Universitair Medisch Centrum0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•Inclusion criteria for ICH due to cerebral hypertensive vasculopathy patients:;In order to be eligible to participate, a subject must meet the following criteria:
•- Intracerebral hemorrhage in the basal ganglia or thalamus in patients with hypertension (defined as known history of hypertension, or on antihypertensive drugs either before or in the chronic phase after ICH). Note: patients with high blood pressure during the period of admission after ICH only without any of the above mentioned criteria will not be included.
•- Subjects are mentally competent to take a decision on participation.
•- Written informed consent
•- Age >55 years;Inclusion criteria for Healthy volunteers
•- Age >55 years
•- Subject is in good health as established by medical history, physical examination
•- MMSE 28 or higher

•- Evidence of recent neurological diseases other than hypertensive cerebral vasculopathy e.g. brain tumors, other vascular conditions (e.g. malformations), inflammatory or infectious disease)
•- Evidence of recent (< 3 months prior to planned lumbar puncture) ischemic or hemorrhagic stroke
•- Presence of blood coagulopathy, established by medical history
•- History of neurological or psychiatric disease
•- Allergy to local anesthetic agents
•- Contra-indication for lumbar puncture: medical history of compression of spinal cord, spinal surgery, skin infection, developmental abnormalities in lower spine
•- Subjects who are currently participating in another study or have participated in a clinical study within the previous 30 days, based on their own report
•- Subjects with a history of drug or alcohol abuse
•- Subjects who are part of the study staff personnel or family members of the study staff personnel;Contraindications for MRI:
•- Intracranial clips
•- Contra-indications to MR Imaging:
•* Claustrophobia
•* Pacemakers and defibrillators
•* Nerve stimulators
•* Intraorbital or intraocular metallic fragments
•* Cochlear implants
•* Ferromagnetic implants
•* Hydrocephalus pump
•* Some intra-uterine device
•* An iron wire behind the teeth placed before 1995
•* Permanent make-up
•* Tattoos above the shoulders
•* Severe physical restriction / inability to be scanned, such as weight above 120 kg
•* Difficulty with lying down for 30 minutes

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