Text Size

Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage (COGHIC-AV45)

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Toulouse
Sponsor:
Collaborators:
Avid Radiopharmaceuticals
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01619709
First received: June 12, 2012
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition Intervention
Non Traumatic Primary Intracerebral Hemorrhage
 Other: Pet AV-45 (Florbetapir F 18) Cerebral Amyloid imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Pet-AV45 cortical binding [ Time Frame: Acute phase of intracerebral hemorrhage ie during the first month after hemorrhage onset. ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • cerebral microbleeds number and distribution on T2EG MRI sequence [ Time Frame: Acute phase of intracerebral hemorrhage ie during the first month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 70
Study Start Date: January 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
lobar hemorrhage group
patients with cortical or corticosubcortical hemorrhage (involving predominantly the cortex and underlying white matter)
 Other: Pet AV-45 (Florbetapir F 18) Cerebral Amyloid imaging
AV-45 (Florbetapir F 18) : Bolus of 5 MBq/kg IV ; A 10-minutes Pet scan acquisition Starts at 50 minutes after injection.
deep hemorrhage group
patients with subcortical hemorrhage (involving predominately the basal ganglia, periventricular white matter, or internal capsule).
 Other: Pet AV-45 (Florbetapir F 18) Cerebral Amyloid imaging
AV-45 (Florbetapir F 18) : Bolus of 5 MBq/kg IV ; A 10-minutes Pet scan acquisition Starts at 50 minutes after injection.

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

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619709

Contacts
Contact: Nicolas Raposo, MD (0)5 61 77 76 40 ext 33 raposo.n@chu-toulouse.fr
Contact: Jérémie Parienté, MD (0)5 61 77 76 40 ext 33 pariente.j@chu-toulouse.fr

Locations
France
Service de neurologie Recruiting
Toulouse, France, 31059
Contact: Nicolas Raposo, MD     (0)5 61 77 76 40 ext 33     raposo.n@chu-toulouse.fr    
Sponsors and Collaborators
University Hospital, Toulouse
Avid Radiopharmaceuticals
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Nicolas Raposo, MD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01619709     History of Changes
Other Study ID Numbers: 1122302, AOL 2011
Study First Received: June 12, 2012
Last Updated: January 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Intracerebral Hemorrhage, Cerebral Amyloid angiopathy, Positron Emission Tomography Amyloid imaging, 18F-AV-45 . Florbetapir, Magnetic Resonance Imaging

Additional relevant MeSH terms:
Hemorrhage
Cognition Disorders
Cerebral Hemorrhage
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Intracranial Hemorrhages
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013