Clinical Trial: Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

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 Summary: 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.
Sponsor: University Hospital, Toulouse

Current Primary Outcome: Pet-AV45 cortical binding [ Time Frame: Acute phase of intracerebral hemorrhage ie during the first month after hemorrhage onset. ]

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)


Original Primary Outcome: Pet-AV45 cortical binding [ Time Frame: Acute phase of intracerebral hemorrhage ie during the first month after hemorrhage onset. ]

Current Secondary Outcome:

  • cerebral microbleeds number and distribution on T2EG MRI sequence [ Time Frame: Acute phase of intracerebral hemorrhage ie during the first month ]
    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 [ Time Frame: Acute phase of intracerebral hemorrhage ie during the first month ]
    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 [ Time Frame: Acute phase of intracerebral hemorrhage ie during the first month ]
    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 [ Time Frame: three months after hemorrhage onset. ]
    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


Original Secondary Outcome:

  • cerebral microbleeds number and distribution on T2EG MRI sequence [ Time Frame: Acute phase of intracerebral hemorrhage ie during the first month ]
  • White Matter Lesions Volume on 3D-FLAIR MRI sequence [ Time Frame: Acute phase of intracerebral hemorrhage ie during the first month ]
  • Cortical thickness and hippocampal volume on 3D-T1 MRI sequence [ Time Frame: Acute phase of intracerebral hemorrhage ie during the first month ]
  • Neuropsychological performances [ Time Frame: three months after hemorrhage onset. ]


Information By: University Hospital, Toulouse

Dates:
Date Received: June 12, 2012
Date Started: January 2012
Date Completion: June 2017
Last Updated: February 21, 2017
Last Verified: February 2017