Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

Study Overview
=================
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.

Official Title
-----------------
Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

Conditions
-----------------
Intracerebral Hemorrhage

Intervention / Treatment
-----------------
* Other: Pet AV-45


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: lobar hemorrhage group<br>PET AV-45 in patients with cortical or corticosubcortical hemorrhage (involving predominantly the cortex and underlying white matter) | Other: Pet AV-45<br>* AV-45 (Florbetapir F 18) : Bolus of 5 MBq/kg IV ; A 10-minutes Pet scan acquisition Starts at 50 minutes after injection.<br>* Other names: PET AV-45 (Florbetapir F 18) Cerebral Amyloid imaging;|
| Other: deep hemorrhage group<br>PET AV-45patients with subcortical hemorrhage (involving predominately the basal ganglia, periventricular white matter, or internal capsule). | Other: Pet AV-45<br>* AV-45 (Florbetapir F 18) : Bolus of 5 MBq/kg IV ; A 10-minutes Pet scan acquisition Starts at 50 minutes after injection.<br>* Other names: PET AV-45 (Florbetapir F 18) Cerebral Amyloid imaging;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Acute phase of intracerebral hemorrhage ie during the first month after hemorrhage onset. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Acute phase of intracerebral hemorrhage ie during the first month | 
| 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 | Acute phase of intracerebral hemorrhage ie during the first month | 
| 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 | Acute phase of intracerebral hemorrhage ie during the first month | 
| 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 | three months after hemorrhage onset. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Amyloid angiopathy, Amyloid imaging, 18F-AV-45, Intracerebral Hemorrhage