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

Primary Purpose

Cerebral Amyloid Angiopathy

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
neurological, neuropsychological and MRI evaluation
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Amyloid Angiopathy focused on measuring intracerebral hemorrhage, cerebral amyloid angiopathy, cortical superficial siderosis, Magnetic Resonance Imaging

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pellegrin Hospital
  • Gui de Chauliac Hospital
  • Lariboisière Hospital
  • CHU Purpan. Hôpital Pierre-Paul Riquet

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients with cortical superficial siderosis.

Patients without cortical superficial siderosis

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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)
mortality or dependance at 12 and 24 months
Mortality and dependence defined by a modified Rankin scale >2
Cognitive decline at 12 and 24 months
moderate or severe vascular cognitive disorders (VCD) according to the VASCOG criteria.
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
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).
frequency of APOE ε2 and ε4 allele
frequency of both ε2 and ε4 allele on Apolipoprotein E (APOE) genotype at baseline

Full Information

First Posted
March 7, 2018
Last Updated
July 27, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03464344
Brief Title
Cortical Superficial Siderosis and Risk of Recurrent Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.
Acronym
CORELIA
Official Title
COrtical Superficial Siderosis and REcurrent Lobar Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 12, 2018 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Amyloid Angiopathy
Keywords
intracerebral hemorrhage, cerebral amyloid angiopathy, cortical superficial siderosis, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with cortical superficial siderosis.
Arm Type
Other
Arm Description
During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation
Arm Title
Patients without cortical superficial siderosis
Arm Type
Other
Arm Description
During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation
Intervention Type
Other
Intervention Name(s)
neurological, neuropsychological and MRI evaluation
Intervention Description
neurological, neuropsychological and MRI evaluation
Primary Outcome Measure Information:
Title
Recurrent symptomatic intracerebral hemorrhage at 24 months
Description
Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Recurrent symptomatic ICH at 12 months
Description
Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms.
Time Frame
12 months
Title
Transient Focal Neurological Episodes (TFNE) at 12 and 24 months
Description
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)
Time Frame
12 and 24 months
Title
mortality or dependance at 12 and 24 months
Description
Mortality and dependence defined by a modified Rankin scale >2
Time Frame
12 and 24 months
Title
Cognitive decline at 12 and 24 months
Description
moderate or severe vascular cognitive disorders (VCD) according to the VASCOG criteria.
Time Frame
12 and 24 months
Title
New MRI hemorrhagic lesion at 12 months
Description
Presence of new symptomatic or asymptomatic hemorrhagic lesion (ICH, microbleeds, convexity subarachnoid hemorrhage) on follow-up MRI at 12 months
Time Frame
12 months
Title
Extent of cortical superficial siderosis at 12 months
Description
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).
Time Frame
12 months
Title
frequency of APOE ε2 and ε4 allele
Description
frequency of both ε2 and ε4 allele on Apolipoprotein E (APOE) genotype at baseline
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas RAPOSO, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lionel CALVIERE
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pellegrin Hospital
City
Bordeaux
Country
France
Facility Name
Gui de Chauliac Hospital
City
Montpellier
Country
France
Facility Name
Lariboisière Hospital
City
Paris
Country
France
Facility Name
CHU Purpan. Hôpital Pierre-Paul Riquet
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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