跳至主要内容
临床试验/NCT01382849
NCT01382849撤回不适用

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

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Type of Bleed

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Type of Bleed

时间窗: 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.

Spot Sign Status

时间窗: 2-3 weeks

They will be further subdivided by spot sign status into positive or negative.

Amyloid uptake

时间窗: 2-3 weeks

次要结局

  • ApoE genotype(2-3 weeks)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验