Short Term Carotid Plaque Regression in Patients With Atherosclerotic Disease Taking Statins Assessed by High Field MRI
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in carotid artery plaque volume assessed by carotid MRI at 6 months
研究概览
简要总结
The purpose of the study is to determine if short term (6 months) treatment with statins to lower low-density lipoprotein (LDL) in vascular disease patients with carotid plaque will be associated with a measurable reduction in carotid plaque volume using 3 Tesla MRI. The researchers will correlate the change in plaque volume to degree of LDL lowering. The researchers will also study if brief treatment will lead to change in plaque composition. The researchers will compare the change in plaque volume measured by 3T MRI with plaque burden measured by ultrasound.
详细描述
Atherosclerotic vascular disease is the leading cause of death in the United States. Atherosclerosis develops with increasing plaque burden and eccentric arterial wall expansion or remodeling, later leading to luminal obstruction. More than 90% of patients with CAD have carotid plaques. Statins have been shown to cause plaque regression in the carotid and coronary arteries. However, there is ongoing controversy about how low the target LDL should be in atherosclerotic patients. The benefits of aggressive LDL lowering with higher statin doses are counterbalanced by the potential for liver and muscle toxicity. High field (3 Tesla) MRI is a promising new modality for measuring plaque volume with high spatial resolution. It is not clear whether increasing statin dose will lead to plaque volume reduction in the short-term (6 months) that can be measured by this new modality.
The primary aim of the study is to determine if LDL lowering using statins in vascular disease patients with carotid plaque will be associated with measurable reduction in carotid plaque volume in the short term (6 months) using 3T MRI.
The four secondary aims of the study are as follows:
To compare the short term carotid plaque volume change using high field MRI in vascular disease patients whose statin dose was increased (dose increased) versus those whose statin dose was maintained (dose maintained).
To determine if increasing statin dose in patients with carotid plaque will lead to measurable change in carotid plaque composition in the short term (6 months) using 3T MRI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in carotid artery plaque volume assessed by carotid MRI at 6 months
时间窗: 6 months
次要结局
- Change in carotid intima media thickness on ultrasound at 6 months(6 months)
- Change in plaque composition by carotid MRI at 6 months(6 months)
- Change in inflammatory markers at 6 months(6 months)
- Change in regional wall shear stress in the carotid artery(6 months)
