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

NCT ID: NCT01382849

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Amyloid Angiopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CAA positive microbleeders

Cerebral amyloid angiopathy (CAA) positive microbleeders

No interventions assigned to this group

probable CAA macrobleeders

No interventions assigned to this group

CAA negative microbleeders

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Sunnybrook Hospital

Principal Investigators

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Richard Aviv

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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18F-AV-45-A14

Identifier Type: -

Identifier Source: org_study_id