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

Cerebral Amyloid Angiopathy Clinical Trial

— CORELIA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03464344
• Other study ID #: RC31/16/8919
• Secondary ID: 2017-A01524-49
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: February 2025

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: February 2025
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cerebral Amyloid Angiopathy
• Cerebral Hemorrhage
• Hemorrhage
• Siderosis

Intervention

Other:
• neurological, neuropsychological and MRI evaluation
neurological, neuropsychological and MRI evaluation

Locations

Country	Name	City	State
France	Pellegrin Hospital	Bordeaux
France	Gui de Chauliac Hospital	Montpellier
France	Lariboisière Hospital	Paris
France	CHU Purpan. Hôpital Pierre-Paul Riquet	Toulouse cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent symptomatic intracerebral hemorrhage at 24 months	Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms	24 months
Secondary	Recurrent symptomatic ICH at 12 months	Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms.	12 months
Secondary	Transient Focal Neurological Episodes (TFNE) at 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)	12 and 24 months
Secondary	mortality or dependance at 12 and 24 months	Mortality and dependence defined by a modified Rankin scale >2	12 and 24 months
Secondary	Cognitive decline at 12 and 24 months	moderate or severe vascular cognitive disorders (VCD) according to the VASCOG criteria.	12 and 24 months
Secondary	New MRI hemorrhagic lesion at 12 months	Presence of new symptomatic or asymptomatic hemorrhagic lesion (ICH, microbleeds, convexity subarachnoid hemorrhage) on follow-up MRI at 12 months	12 months
Secondary	Extent of cortical superficial siderosis at 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).	12 months
Secondary	frequency of APOE e2 and e4 allele	frequency of both e2 and e4 allele on Apolipoprotein E (APOE) genotype at baseline	baseline