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F-18-AV-45 Uptake, Spot Sign Presence and Cerebral Amyloid Angiopathy (CAA) in Primary Intracranial Hemorrhage (ICH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01382849
Recruitment Status : Withdrawn
First Posted : June 27, 2011
Last Update Posted : November 19, 2014
Information provided by:
Sunnybrook Health Sciences Centre

Brief Summary:

Florbetapir F 18 is an experimental radioactive drug that may allow doctors to image changes in the brain using a PET (Positron Emission Tomography) scanner. The purpose of this study is to evaluate the imaging characteristics of, Florbetapir F 18 (also known as 18F-AV-45) in patients who have previously undergone bleeding in their brains. Florbetapir F 18 binds to amyloid-ß peptide (Aß) that accumulates in the brains of patients with bleeding. These accumulations are called amyloid plaques and when extensive are labeled cerebral amyloid angiopathy (CAA). Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a PET camera.

MRI detected microbleeds have been identified as markers of clinically silent hemorrhage from bleeding-prone vessels. Another imaging marker of vessel damage and risk of bleeding is the spot sign (SS). Finally, certain genetic signatures (ApoE genotype) have been shown to be associated with Aß deposition in the brain or predispose patients to higher risks of bleeding. This research study will explore the interactions of these factors and understand the physiology of intracerebral bleeding.

Condition or disease
Cerebral Amyloid Angiopathy

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: F-18-AV-45 Uptake, Spot Sign Presence and Cerebral Amyloid Angiopathy (CAA) in Primary Intracranial Hemorrhage (ICH)
Study Start Date : August 2011
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

CAA positive microbleeders
Cerebral amyloid angiopathy (CAA) positive microbleeders
probable CAA macrobleeders
CAA negative microbleeders

Primary Outcome Measures :
  1. Type of Bleed [ Time Frame: 2-3 weeks ]
    Patients will be divided into micro- and macro- bleeders based on MRI detected microhemorhage pattern. Processing of each patient will take 2-3 weeks.

  2. Spot Sign Status [ Time Frame: 2-3 weeks ]
    They will be further subdivided by spot sign status into positive or negative.

  3. Amyloid uptake [ Time Frame: 2-3 weeks ]

Secondary Outcome Measures :
  1. ApoE genotype [ Time Frame: 2-3 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Macrobleed patients will be selected from a prospectively maintained ICH database at Sunnybrook Hospital.

Inclusion Criteria:

  • Prior intracranial hemorrhage at least 3 months prior
  • Patients >18 years

Exclusion Criteria:

  1. Modified Rankin score >3.
  2. Clinically significant medical comorbidities which in the opinion of the investigator might pose a potential safety risk to the subject.
  3. Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
  4. Have a history of relevant severe drug allergy or hypersensitivity
  5. Patients who withdraw consent. Age and gender-matched microbleed patients previously demonstrating MRI microbleeds without prior macrobleeds will be recruited from stroke clinic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01382849

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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Principal Investigator: Richard Aviv Sunnybrook Health Sciences Centre

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Responsible Party: Richard I Aviv, Sunnybrook Hospital Identifier: NCT01382849    
Other Study ID Numbers: 18F-AV-45-A14
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Keywords provided by Sunnybrook Health Sciences Centre:
cerebral amyloid angiopathy
cerebral spot sign
Additional relevant MeSH terms:
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Intracranial Hemorrhages
Cerebral Amyloid Angiopathy
Cerebral Amyloid Angiopathy, Familial
Pathologic Processes
Proteostasis Deficiencies
Metabolic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Cerebral Small Vessel Diseases
Amyloidosis, Familial
Metabolism, Inborn Errors
Genetic Diseases, Inborn