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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Recruiting

CT.gov ID

NCT03464344

Collaborator

(none)

169

Enrollment

Locations

Arms

47.6

Anticipated Duration (Months)

42.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Amyloid Angiopathy	Other: neurological, neuropsychological and MRI evaluation	N/A

Detailed Description

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. without cSS.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

169 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

COrtical Superficial Siderosis and REcurrent Lobar Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.

Actual Study Start Date :

Oct 12, 2018

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with cortical superficial siderosis. During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation	Other: neurological, neuropsychological and MRI evaluation 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	Other: neurological, neuropsychological and MRI evaluation neurological, neuropsychological and MRI evaluation

Arm

Intervention/Treatment

Other: Patients with cortical superficial siderosis.

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

Other: neurological, neuropsychological and MRI evaluation

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

Other: neurological, neuropsychological and MRI evaluation

neurological, neuropsychological and MRI evaluation

Outcome Measures

Primary Outcome Measures

Recurrent symptomatic intracerebral hemorrhage at 24 months [24 months]
Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms

Secondary Outcome Measures

Recurrent symptomatic ICH at 12 months [12 months]
Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms.
Transient Focal Neurological Episodes (TFNE) at 12 and 24 months [12 and 24 months]
TFNE was defined as transient (≤24 hours), with fully resolving, focal neurological symptoms that had no known alternative explanation other than CAA (e.g., structural brain lesion, atrial fibrillation, extracranial, or intracranial stenosis)
mortality or dependance at 12 and 24 months [12 and 24 months]
Mortality and dependence defined by a modified Rankin scale >2
Cognitive decline at 12 and 24 months [12 and 24 months]
moderate or severe vascular cognitive disorders (VCD) according to the VASCOG criteria.
New MRI hemorrhagic lesion at 12 months [12 months]
Presence of new symptomatic or asymptomatic hemorrhagic lesion (ICH, microbleeds, convexity subarachnoid hemorrhage) on follow-up MRI at 12 months
Extent of cortical superficial siderosis at 12 months [12 months]
Extent of cSS is assessed on follow up MRI at 12 months according to the current guidelines: 0: no cSS; 1: focal cSS (restricted to ≤3 sulci); 2: disseminated cSS (≥4 sulci).
frequency of APOE ε2 and ε4 allele [baseline]
frequency of both ε2 and ε4 allele on Apolipoprotein E (APOE) genotype at baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Pellegrin Hospital	Bordeaux	France
2	Gui de Chauliac Hospital	Montpellier	France
3	Lariboisière Hospital	Paris	France
4	CHU Purpan. Hôpital Pierre-Paul Riquet	Toulouse cedex 9	France	31059