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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Purpan. Hôpital Pierre-Paul Riquet, Toulouse cedex 9, France

Status

Recruiting

Address

CHU Purpan. Hôpital Pierre-Paul Riquet

Toulouse cedex 9, , 31059

Site Contact

Nicolas RAPOSO, MD

raposo.n@chu-toulouse.fr

5 61 77 76 40

Lariboisière Hospital, Paris, France

Status

Recruiting

Address

Lariboisière Hospital

Paris, ,

Site Contact

Eric JOUVENT

raposo.n@chu-toulouse.fr

5 61 77 76 40

Gui de Chauliac Hospital, Montpellier, France

Status

Not yet recruiting

Address

Gui de Chauliac Hospital

Montpellier, ,

Site Contact

Caroline ARQUIZAN

raposo.n@chu-toulouse.fr

5 61 77 76 40

Pellegrin Hospital, Bordeaux, France

Status

Recruiting

Address

Pellegrin Hospital

Bordeaux, ,

Site Contact

Igor SIBON

raposo.n@chu-toulouse.fr

5 61 77 76 40

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