Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

NCT01619709 | Completed

• 2 other identifiers: 11 223 02AOL 2011
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral Hemorrhage; Cerebral Amyloid angiopathy; Amyloid imaging; 18F-AV-45

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• cerebral microbleeds number and distribution on T2EG MRI sequence

  Acute phase of intracerebral hemorrhage ie during the first month

• White Matter Lesions Volume on 3D-FLAIR MRI sequence

  Acute phase of intracerebral hemorrhage ie during the first month

• Cortical thickness and hippocampal volume on 3D-T1 MRI sequence

  Acute phase of intracerebral hemorrhage ie during the first month

• Neuropsychological performances

  three months after hemorrhage onset.

Study Arms (2)

lobar hemorrhage group

OTHER

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

Other: Pet AV-45

deep hemorrhage group

OTHER

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

Other: Pet AV-45

Interventions

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.

Also known as: PET AV-45 (Florbetapir F 18) Cerebral Amyloid imaging

deep hemorrhage group; lobar hemorrhage group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Avid Radiopharmaceuticals: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Service de neurologie

Toulouse, 31059, France

Location

Related Publications (2)

• 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.

  PMID: 32394598 DERIVED

• 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.

  PMID: 28570698 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage; Cerebral Amyloid Angiopathy

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nicolas Raposo, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 21, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)