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Cortical Superficial Siderosis and Risk of Recurrent Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.

Study Purpose

Cerebral amyloid angiopathy (CAA) is a major cause of lobar intracerebral hemorrhage (ICH) in the elderly with high risk of recurrence. The investigators aim to determine the relationship between cortical superficial siderosis (cSS), a MRI hemorrhagic marker of CAA and the risk of symptomatic ICH recurrence in a multicentric prospective cohort of patients with acute lobar ICH related to CAA. The investigators hypothesize that patients with cSS have an increased risk of recurrent symptomatic ICH relative to those without cSS.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	55 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Lobar ICH within 30 days after onset.

- Available brain MRI sequences of adequate quality including fluid-attenuated inversion recovery (FLAIR) and T2*-weighted gradient-recalled echo (T2*-GRE) sequences.

- Modified Boston criteria for probable or possible CAA.

- Age ≥ 55 years.

- Written consent.

Exclusion Criteria:

- Secondary brain hemorrhage : vascular malformation (arteriovenous malformation, aneurysm, cavernous); cerebral veinous thrombosis; brain tumor; coagulopathy; vasculitis; hemorrhagic infarction, - Infratentorial siderosis.

- Contraindications to MRI.

- Neurosurgical intervention before inclusion, - Progressive neoplasm.

- Patient without affiliation to the french social security.

- Patient under guardianship

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03464344
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Toulouse
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Nicolas RAPOSO, MDLionel CALVIERE
Principal Investigator Affiliation	University Hospital, ToulouseUniversity Hospital, Toulouse
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cerebral Amyloid Angiopathy

Additional Details

Patients with acute lobar ICH fulfilling the Boston criteria for probable or possible CAA will be enrolled within 30 days after ICH onset. Brain MRI performed at baseline will be analyzed blinded to clinical data. Patients with presence of cSS will be compared with those without cSS. During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation. The investigators will compare the rate of recurrent symptomatic ICH at 24 months in patients with vs.#46; without cSS.

Arms & Interventions

Arms

Other: Patients with cortical superficial siderosis.

During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation

Other: Patients without cortical superficial siderosis

During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation

Interventions

Other: - neurological, neuropsychological and MRI evaluation

neurological, neuropsychological and MRI evaluation

Contact a Trial Team

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