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Intracerebral Hemorrhage | Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

Intracerebral Hemorrhage research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Intracerebral Hemorrhage

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Pet AV-45AV-45 (Florbetapir F 18) : Bolus of 5 MBq/kg IV ; A 10-minutes Pet scan acquisition Starts at 50 minutes after injection.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

lobar hemorrhage groupPET AV-45 in patients with cortical or corticosubcortical hemorrhage (involving predominantly the cortex and underlying white matter)

deep hemorrhage groupPET AV-45patients with subcortical hemorrhage (involving predominately the basal ganglia, periventricular white matter, or internal capsule).

Study Status

Completed

Start Date: January 2012

Completed Date: June 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Pet-AV45 cortical binding

Secondary Outcome: cerebral microbleeds number and distribution on T2EG MRI sequence

Study sponsors, principal investigator, and references

Principal Investigator: Nicolas Raposo, MD

Lead Sponsor: University Hospital, Toulouse

Collaborator: Avid Radiopharmaceuticals

More information:https://clinicaltrials.gov/show/NCT01619709

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