Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

— COGHIC-AV45  

Official title:

Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619709
• Other study ID #: 11 223 02
• Secondary ID: AOL 2011
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: June 2017

Study information

• Verified date: September 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cerebral Hemorrhage
• Cognitive Dysfunction
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

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

Locations

Country	Name	City	State
France	Service de neurologie	Toulouse

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Avid Radiopharmaceuticals, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.