Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in blood brain barrier permeability over three months for the treatment group compared to the control group.
研究概览
简要总结
Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. In some patients, CCMs affect the blood brain barrier (BBB). The BBB is the body's separation of blood and its contents in the brain from the brain tissue itself. Abnormal leakiness or permeability of this barrier can cause disease. We will measure the permeability (leakiness) of the BBB using a magnetic resonance imaging (MRI) technique called dynamic contrast-enhanced MRI (DCEMRI). The purpose of this study is to look at whether statin medications change the permeability (leakiness) of the blood brain barrier in CCM patients. Statin medications are used to lower cholesterol levels and prevent heart attack and stroke. In addition, this medication may decrease the risk of brain hemorrhage or bleeding in patients with CCM. This study will examine whether the permeability of the BBB changes following the administration of simvastatin for three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cerebral cavernous malformations-common Hispanic mutation (CCM1-CHM)
- •Must be willing to travel to the University of New Mexico in Albuquerque, NM for 5 visits over the course of three months.
排除标准
- •Incarceration
- •Unable to pass MRI safety screening (pregnant females, claustrophics, or those with certain metallic items implanted in their bodies)
- •Low kidney function or transplants, an eGFR below 60 mL/min
- •Currently taking statin medications or have taken statin medications in the past 6 months
- •Known allergy or intolerance to statins
- •Known allergy or intolerance to gadolinium
- •Liver dysfunction at baseline, AST > 47 and/or ALT > 49
- •Consumption of large quantities of alcohol, men who consume more than 2 daily drinks and women who consume more than one daily drink
- •CK level of 232 or higher
- •Triglycerides greater than or equal to
- •Medications: gemfibrozil, cyclosporine, danazol, itraconazole, ketoconazole, posaconazole, ethromycin, clarithomycin, telithromycin, HIV protease inhibitors, nefazoldone, amiodarone, verapamil, dilitiazem, amlodipine, or ranalazine
研究组 & 干预措施
Simvastatin
20-40 mg tablet taken daily by mouth. Month 1: 20 mg; Months 2 and 3: 40 mg.
干预措施: Simvastatin (Drug)
结局指标
主要结局
Change in blood brain barrier permeability over three months for the treatment group compared to the control group.
时间窗: Baseline, Three Months
We will measure the change in blood brain barrier permeability with dynamic contrast enhanced MRI from baseline to three months. We will compare the change in permeability for a group of CCM patients placed on statin medication (treatment group) with a group of CCM patients not on statin medication (control group).
次要结局
- Correlation of physiologic permeability data with anatomic lesion data(Baseline, Three months)
研究者
Leslie Morrison
Vice Chancellor for Academic Affairs
University of New Mexico