Clinical trial NCT01619709: Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage
Official title: Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral Hemorrhage
Cerebral Amyloid angiopathy
Amyloid imaging
18F-AV-45
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Avid Radiopharmaceuticals
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2012-06-14
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Pet-AV45 cortical binding
timeFrame: Acute phase of intracerebral hemorrhage ie during the first month after hemorrhage onset.
Secondary outcomes:
measure: cerebral microbleeds number and distribution on T2EG MRI sequence
timeFrame: Acute phase of intracerebral hemorrhage ie during the first month
measure: White Matter Lesions Volume on 3D-FLAIR MRI sequence
timeFrame: Acute phase of intracerebral hemorrhage ie during the first month
measure: Cortical thickness and hippocampal volume on 3D-T1 MRI sequence
timeFrame: Acute phase of intracerebral hemorrhage ie during the first month
measure: Neuropsychological performances
timeFrame: three months after hemorrhage onset.
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Service de neurologie
Study officials:
affiliation: University Hospital, Toulouse
name: Nicolas Raposo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.