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

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ClinicalTrials.gov Identifier: NCT03464344
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 12, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Recurrent symptomatic intracerebral hemorrhage at 24 months [ Time Frame: 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 :
  1. Recurrent symptomatic ICH at 12 months [ Time Frame: 12 months ]
    Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms.

  2. Transient Focal Neurological Episodes (TFNE) at 12 and 24 months [ Time Frame: 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)

  3. mortality or dependance at 12 and 24 months [ Time Frame: 12 and 24 months ]
    Mortality and dependence defined by a modified Rankin scale >2

  4. Cognitive decline at 12 and 24 months [ Time Frame: 12 and 24 months ]
    moderate or severe vascular cognitive disorders (VCD) according to the VASCOG criteria.

  5. New MRI hemorrhagic lesion at 12 months [ Time Frame: 12 months ]
    Presence of new symptomatic or asymptomatic hemorrhagic lesion (ICH, microbleeds, convexity subarachnoid hemorrhage) on follow-up MRI at 12 months

  6. Extent of cortical superficial siderosis at 12 months [ Time Frame: 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).

  7. frequency of APOE ε2 and ε4 allele [ Time Frame: baseline ]
    frequency of both ε2 and ε4 allele on Apolipoprotein E (APOE) genotype at baseline



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464344


Contacts
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Contact: Nicolas RAPOSO, MD 5 61 77 76 40 ext 33 raposo.n@chu-toulouse.fr

Locations
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France
Pellegrin Hospital Recruiting
Bordeaux, France
Contact: Igor SIBON         
Gui de Chauliac Hospital Not yet recruiting
Montpellier, France
Contact: Caroline ARQUIZAN         
Lariboisière Hospital Recruiting
Paris, France
Contact: Eric JOUVENT         
CHU Purpan. Hôpital Pierre-Paul Riquet Recruiting
Toulouse cedex 9, France, 31059
Contact: Nicolas RAPOSO, MD         
Sub-Investigator: Christophe Cognard, PHD         
Sub-Investigator: Jacques Izopet, PHD         
Sub-Investigator: Claire Thalamas, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Nicolas RAPOSO, MD University Hospital, Toulouse
Principal Investigator: Lionel CALVIERE University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03464344     History of Changes
Other Study ID Numbers: RC31/16/8919
2017-A01524-49 ( Other Identifier: ID-RCB )
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
intracerebral hemorrhage
cerebral amyloid angiopathy
cortical superficial siderosis
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Siderosis
Cerebral Hemorrhage
Cerebral Amyloid Angiopathy
Cerebral Amyloid Angiopathy, Familial
Amyloidosis
Hemorrhage
Pathologic Processes
Proteostasis Deficiencies
Metabolic Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Cerebral Small Vessel Diseases
Amyloidosis, Familial
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Pneumoconiosis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases