Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage (COGHIC-AV45)
Primary Purpose
Intracerebral Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pet AV-45
Sponsored by
About this trial
This is an interventional basic science trial for Intracerebral Hemorrhage focused on measuring Intracerebral Hemorrhage, Cerebral Amyloid angiopathy, Amyloid imaging, 18F-AV-45
Eligibility Criteria
Inclusion Criteria:
- Age : 40-90 years,
- Non traumatic primary intracerebral hemorrhage during acute phase (less than 30 days from hemorrhage onset) confirmed on brain imaging (CT and/or MRI).
- Correct visual, hearing and language functions to perform neuropsychological tests.
- Written consent of patient
Exclusion Criteria:
- Secondary causes of intracerebral hemorrhage : vascular malformations (Arteriovenous malformation, intracranial aneurysm, Cavernous angioma, dural arteriovenous fistula), cerebral venous thrombosis, intracranial neoplasm, coagulopathy, vascularitis, Cocaine or alcohol use, Hemorrhagic ischemic stroke.
- Pregnancy
- Contraindication to MRI
- progressive neoplasm
- Cognitive impairment secondary to progressive neurological disease
- Depression,
- Drug addiction
Sites / Locations
- Service de neurologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
lobar hemorrhage group
deep hemorrhage group
Arm Description
PET AV-45 in patients with cortical or corticosubcortical hemorrhage (involving predominantly the cortex and underlying white matter)
PET AV-45patients with subcortical hemorrhage (involving predominately the basal ganglia, periventricular white matter, or internal capsule).
Outcomes
Primary Outcome Measures
Pet-AV45 cortical binding
Method of administration: a bolus IV injection (less than 1 minute of injection time) of 5 MBq / kg with a maximum of 370MBq. The activity corresponding to a 70 kg individual is 350 MBq and corresponds to an effective dose of 12.25mSv (0.035mSv/MBq)
Secondary Outcome Measures
cerebral microbleeds number and distribution on T2EG MRI sequence
Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed
White Matter Lesions Volume on 3D-FLAIR MRI sequence
Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed
Cortical thickness and hippocampal volume on 3D-T1 MRI sequence
Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed
Neuropsychological performances
a neuropsychological examination (tests of memory, language and attention) will be realized. This examination will last approximately 60 minutes and take place in consultation with neurology
Full Information
NCT ID
NCT01619709
First Posted
June 12, 2012
Last Updated
September 20, 2018
Sponsor
University Hospital, Toulouse
Collaborators
Avid Radiopharmaceuticals, Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT01619709
Brief Title
Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage
Acronym
COGHIC-AV45
Official Title
Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Avid Radiopharmaceuticals, Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate Pet AV-45 Amyloid imaging in the etiological diagnosis of primary non traumatic intracerebral hemorrhage (Cerebral Amyloid Angiopathy and hypertension related hemorrhage).We hypothesize that patients with lobar hemorrhage (probably related to Cerebral Amyloid Angiopathy) will have a greater AV45 cortical binding than patients with deep hemorrhage (probably related to hypertension).
Detailed Description
Cerebral Amyloid Angiopathy (CAA) and hypertension related hemorrhage are the main causes of non traumatic primary intracerebral hemorrhage. In vivo diagnosis of these two cerebral diseases may be difficult and is based on hematoma location and pattern of cerebral microbleeds (CMB) distribution. We aimed to evaluate a multimodal approach including brain MRI, Pet AV-45 Amyloid imaging and neuropsychological assessment to improve etiological diagnosis of primary intracerebral hemorrhage. 70 patients with acute primary non traumatic intracerebral hemorrhage will be prospectively included and two groups will be compared: lobar hemorrhage group and deep hemorrhage group. Brain MRI, Pet AV-45 Cerebral Amyloid imaging (during the first month) and neuropsychological assessment (Three months later) are performed. Differences between the two groups are evaluated for AV45 cortical binding, CMB distribution, White Matter Lesions and cognitive profile.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
Intracerebral Hemorrhage, Cerebral Amyloid angiopathy, Amyloid imaging, 18F-AV-45
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lobar hemorrhage group
Arm Type
Other
Arm Description
PET AV-45 in patients with cortical or corticosubcortical hemorrhage (involving predominantly the cortex and underlying white matter)
Arm Title
deep hemorrhage group
Arm Type
Other
Arm Description
PET AV-45patients with subcortical hemorrhage (involving predominately the basal ganglia, periventricular white matter, or internal capsule).
Intervention Type
Other
Intervention Name(s)
Pet AV-45
Other Intervention Name(s)
PET AV-45 (Florbetapir F 18) Cerebral Amyloid imaging
Intervention Description
AV-45 (Florbetapir F 18) : Bolus of 5 MBq/kg IV ; A 10-minutes Pet scan acquisition Starts at 50 minutes after injection.
Primary Outcome Measure Information:
Title
Pet-AV45 cortical binding
Description
Method of administration: a bolus IV injection (less than 1 minute of injection time) of 5 MBq / kg with a maximum of 370MBq. The activity corresponding to a 70 kg individual is 350 MBq and corresponds to an effective dose of 12.25mSv (0.035mSv/MBq)
Time Frame
Acute phase of intracerebral hemorrhage ie during the first month after hemorrhage onset.
Secondary Outcome Measure Information:
Title
cerebral microbleeds number and distribution on T2EG MRI sequence
Description
Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed
Time Frame
Acute phase of intracerebral hemorrhage ie during the first month
Title
White Matter Lesions Volume on 3D-FLAIR MRI sequence
Description
Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed
Time Frame
Acute phase of intracerebral hemorrhage ie during the first month
Title
Cortical thickness and hippocampal volume on 3D-T1 MRI sequence
Description
Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed
Time Frame
Acute phase of intracerebral hemorrhage ie during the first month
Title
Neuropsychological performances
Description
a neuropsychological examination (tests of memory, language and attention) will be realized. This examination will last approximately 60 minutes and take place in consultation with neurology
Time Frame
three months after hemorrhage onset.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age : 40-90 years,
Non traumatic primary intracerebral hemorrhage during acute phase (less than 30 days from hemorrhage onset) confirmed on brain imaging (CT and/or MRI).
Correct visual, hearing and language functions to perform neuropsychological tests.
Written consent of patient
Exclusion Criteria:
Secondary causes of intracerebral hemorrhage : vascular malformations (Arteriovenous malformation, intracranial aneurysm, Cavernous angioma, dural arteriovenous fistula), cerebral venous thrombosis, intracranial neoplasm, coagulopathy, vascularitis, Cocaine or alcohol use, Hemorrhagic ischemic stroke.
Pregnancy
Contraindication to MRI
progressive neoplasm
Cognitive impairment secondary to progressive neurological disease
Depression,
Drug addiction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Raposo, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de neurologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32394598
Citation
Planton M, Pariente J, Nemmi F, Albucher JF, Calviere L, Viguier A, Olivot JM, Salabert AS, Payoux P, Peran P, Raposo N. Interhemispheric distribution of amyloid and small vessel disease burden in cerebral amyloid angiopathy-related intracerebral hemorrhage. Eur J Neurol. 2020 Aug;27(8):1664-1671. doi: 10.1111/ene.14301. Epub 2020 May 31.
Results Reference
derived
PubMed Identifier
28570698
Citation
Planton M, Saint-Aubert L, Raposo N, Branchu L, Lyoubi A, Bonneville F, Albucher JF, Olivot JM, Peran P, Pariente J. High prevalence of cognitive impairment after intracerebral hemorrhage. PLoS One. 2017 Jun 1;12(6):e0178886. doi: 10.1371/journal.pone.0178886. eCollection 2017.
Results Reference
derived
Learn more about this trial
Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage
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