Aspirin as a Promising Agent to Attenuate Inflammation in the Wall of Human Cerebral Aneurysms
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- measurement of inflammatory biomarkers
研究概览
简要总结
Hypothesis: aspirin attenuates inflammation in cerebral aneurysms and hence reduces the incidence of rupture. This effect can be monitored using the signal generated by macrophages (inflammatory biomarker) in ferumoxytol-enhanced MRI.
Study aims:
- Determine if daily aspirin intake (for three months) would obliterate/reduce ferumoxytol-enhanced MRI signal changes generated by macrophages in cerebral aneurysm wall. Fifteen patients with cerebral aneurysms > 7 mm will be selected to enroll in this pilot study. 10 patients will be imaged at base line with ferumoxytol-enhanced MRI. Following that, they will take aspirin 81 mg daily and then re-imaged again at three months. This group will be compared to a control group of 5 patients where they will have the imagings studies performed at base line and at three months but will NOT take aspirin.
详细描述
If you are eligible to enroll in the study, you will be contacted by the principal investigator in person and he will describe the study in a private setting (neurosurgery clinic room or hospital patient room). You will be given ample opportunity to decide to participate or not.
You will be randomly assigned to receive one of the 2 study treatments, either taking aspirin or not. This means that whichever study treatment you receive will be determined purely by chance, like flipping a coin. You will have a 2 out of 3 chance of receiving the study treatment (aspirin). You will be told which study treatment arm you are on.
A 15 minute base line MRI of the brain will be performed initially. Following that, the medication (ferumoxytol) will be injected intravenously over 3 minutes. The second MRI of the brian will obtained 24 hours later. A third MRI will be obtained also at 72 hours following the injection of medication. Then after the third MRI, ten people will be chosen randomly to start aspirin every day for three months total. The selected aspirin group will be given 3-month supply of aspirin (81 mg). The other five patients will be asked to avoid any anti-inflammatory drugs (like aspirin, Advil, ibuprofen, ...) if at all possible. Following an interval of three months, a repeat MRI of the brain will be done exactly as above (a base line MRI of the brain will be done, then the medication will be injected intravenously (IV). A second MRI will be obtained 24 hours later followed by another one at 72 hours later.
MRI scans:
An MRI scanner takes pictures of the inside of your brain. You will be asked to lie on your back on a special table that slides into the tube. The sides of the tube will be fairly close to your body and the scanner makes a loud hammering noise while you are inside. You will be able to talk to people in the room through a speaker system. We will monitor you closely while you are inside the scanner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-80 years.
- •Incidental (non-ruptured) IA ≥5 mm.
- •Treating neurosurgeon and patient agree on observation period of 3 months before proceeding with treatment either endovascularly or by microsurgical clipping.
- •Positive MRI signal change corresponding of ferumoxytol uptake is observed.
- •No history of aspirin intake or NSAIDs for 4 weeks prior to enrolment.
- •No current history of statin use.
排除标准
- •Patients with treated IAs (by coil embolization or surgical clipping) will be excluded.
- •Patients presenting with ruptured intracranial IAs will also be excluded from the study, to avoid interfering with timely treatment of ruptured IAs.
- •pregnant women
- •persons with history of allergy or hypersensitivity to iron or dextran or iron-polysaccharide preparations
- •patients requiring monitored anesthesia or intravenous (IV) sedation for MR imaging
- •patients with contraindication to MRI
- •patients with renal insufficiency, hepatic insufficiency or iron overload,
- •patients receiving combination antiretroviral therapy.
研究组 & 干预措施
aspirin
aspirin 81 mg po every day
干预措施: aspirin (Drug)
结局指标
主要结局
measurement of inflammatory biomarkers
时间窗: 3 months
At the end of treatment, Inflammatory biomarkers are used to assess the efficacy of treatment (aspirin)
次要结局
- change in the signal intensity of MRI(3 months)
研究者
David Hasan
Assistant Professor and Section Chief
University of Iowa