Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT05499169
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 55y
2. Ability and willingness to provide written informed consent.
3. Supratentorial ICH with CAA or HA as the most likely cause.
Exclusion Criteria:
1. Age \< 55y
2. Unable to provide informed consent.
3. Pre-existing cognitive impairment assessed with the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); scores between 53 - 63 reflect pre-existing cognitive impairment
4. Contra indications, such as: Contra-indications for 3T MRI. Examples of possible contra-indications are:
* Claustrophobia
* Pacemakers and defibrillators
* Nerve stimulators
* Intracranial clips
* Intra-orbital or intraocular metallic fragments
* Cochlear implants
* Ferromagnetic implants
* Hydrocephalus pump
* Intra-uterine device
* Permanent make-up
* Tattoos above the shoulders
* Reduced kidney function (estimated GFR \< 30 ml/min/1,73m2; or nephrogenic systemic fibrosis / nephrogenic fibrosing nephropathy (NSF/NFD))
* Known prior allergic reaction to gadolinium contrast or one of the constituents of its solution for administration
Contraindications for lumbar puncture:
* Intracranial tumor
* Compressio medullae
* Signs and symptoms of increased intracranial pressure
* Local infections of the skin
* A coagulopathy including use of anti-coagulant drugs (INR ≥ 1.8) or thrombocytopenia (\<40)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT05499169
Study Brief:
Protocol Section:
NCT05499169