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Completed

NCT Number: NCT01619709

Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pet AV-45

Other

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

Other names: PET AV-45 (Florbetapir F 18) Cerebral Amyloid imaging

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Avid Radiopharmaceuticals
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: COGHIC-AV45

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2012
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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