Muscle Characteristics Associated With Statin Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Atrogin-1 expression.
研究概览
简要总结
The purpose of this study is to investigate the mechanism of statin-related myopathy by evaluating muscle samples before and after statin exposure.
详细描述
Statins have been proven to reduce cardiovascular events and mortality in large clinical trials but remain underutilized partly due to the associated myopathy. Severe reactions manifested as rhabdomyolysis are rare but myalgia is commonly noted in clinical practice. The pathophysiology of these events remains obscure. Previous studies suggest that statins block the downstream products (such as cellular signaling molecules) of the mevalonate pathway needed for normal muscle function. Other studies show that statins are associated with gene expressions involved in muscle damage such as atrogin-1. We will quantify these entities pre and post statin therapy to better understand these reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary surgeon's permission.
- •Patient is > 21 years of age.
- •Patient will go through a two phase surgery with the two procedures one to eight months apart.
- •Patient or representative understands the nature of the study.
- •Normal thyroid stimulating hormone (TSH).
- •LDL-cholesterol > 100 mg/dL or highly sensitive C-reactive protein (hsCRP) > 2.
- •One of the following risk factors: male > 45 year old or female > 55 year old, smoker, hypertension, first degree family history of coronary artery disease < 55 year old, HDL <40 mg/dL, chronic kidney disease, diabetes mellitus, previous TIA or stroke, previous coronary artery disease.
排除标准
- •Has been on a lipid-lowering medication previously.
- •Severe illness (e.g. trauma or sepsis) more than 24 hours before obtaining the first biopsy.
- •Less than a 10% reduction of LDL after 3 months of therapy (indicative of non-adherence).
- •Contraindications to statins such as liver failure.
- •History of underlying muscle disorder.
- •Taking amiodarone.
研究组 & 干预措施
Statin exposure
Subjects' endpoints will be measured before and after one to eight months of statin exposure.
干预措施: simvastatin (Drug)
结局指标
主要结局
Atrogin-1 expression.
时间窗: One to eight months.
Intramuscular Ras level.
时间窗: One to eight months.
次要结局
- Intramuscular Coenzyme Q10 level.(One to eight months.)
- PPAR-gamma coactivator-1-alpha expression.(One to eight months.)
- Intramuscular mitochondrial to nuclear DNA ratio.(One to eight months.)
- Intramuscular geranylgeranylpyrophosphate.(One to eight months.)