Investigating the link between cortical superficial siderosis and recurrent brain hemorrhage in patients with cerebral amyloid angiopathy
COrtical Superficial Siderosis and REcurrent Lobar Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.
This study is trying to see if having cortical superficial siderosis affects the chances of older patients with cerebral amyloid angiopathy having more brain bleeding episodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 4 sites (Bordeaux and 3 other locations) |
| Trial ID | NCT03464344 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between cortical superficial siderosis (cSS) and the risk of recurrent symptomatic intracerebral hemorrhage (ICH) in patients diagnosed with cerebral amyloid angiopathy (CAA). Patients aged 55 and older who have experienced acute lobar ICH will be enrolled within 30 days of onset and will undergo brain MRI to assess the presence of cSS. The study will follow participants for 24 months, conducting neurological, neuropsychological, and MRI evaluations to compare the recurrence rates of symptomatic ICH between those with and without cSS.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 and older who have experienced a lobar ICH within the last 30 days and meet the criteria for probable or possible CAA.
Not a fit: Patients with secondary brain hemorrhages or those with contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at higher risk for recurrent brain hemorrhages, allowing for better management and preventive strategies.
How similar studies have performed: While the specific relationship between cSS and recurrent ICH in CAA is being investigated here, similar studies have shown promising results in understanding risk factors for recurrent hemorrhagic events.
Eligibility criteria
Show full 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
Where this trial is running
Bordeaux and 3 other locations
- Pellegrin Hospital — Bordeaux, France (Recruiting)
- Gui de Chauliac Hospital — Montpellier, France (Not_yet_recruiting)
- Lariboisière Hospital — Paris, France (Recruiting)
- CHU Purpan. Hôpital Pierre-Paul Riquet — Toulouse cedex 9, France (Recruiting)
Study contacts
- Principal investigator: Nicolas RAPOSO, MD — University Hospital, Toulouse
- Study coordinator: Nicolas RAPOSO, MD
- Email: raposo.n@chu-toulouse.fr
- Phone: 5 61 77 76 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.