The Effect of Acute Statin Treatment on Inflammation and Peripheral Arterial Tone in Patients Undergoing Percutaneous Coronary Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Change in Serum High Sensitivity C-Reactive Protein (hsCRP)
研究概览
简要总结
The goal of this study is to determine if one dose of simvastatin will decrease the inflammatory response to coronary intervention. Also to determine if one dose of simvastatin affects endothelial function (activity of the artery) as measured by noninvasive peripheral artery tonography.
详细描述
The objective of this study is to determine if acute pretreatment with simvastatin, an HMG-CoA reductase inhibitor will reduce the post inflammatory response after percutaneous coronary interventions (PCI), and/or change endothelial function as assessed by peripheral arterial tomography (PAT). Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty or simply angioplasty, is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease.
Patients will be pretreated with simvastatin 80 mg prior to undergoing PCI. Endothelial function will be assessed before and after treatment via PAT. Our working hypothesis is patients pretreated with simvastatin, will have 1) attenuated inflammatory response, as noted by decreased levels of serum high sensitivity CRP and IL-6 and 2) improved endothelial function as compared to patients not pretreated with statin therapy.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Patients undergoing PCI/angiography
- •No previously known side effects of statins
- •Patients who sign an informed consent
- •Age > 18 years old
排除标准
- •Patients with ST elevation myocardial infarction
- •Patients with cardiogenic shock
- •Patients with hypersensitivity to statins
- •Patients with unexplained muscle pain
- •Patients with acute liver disease
- •Patients receiving cyclosporine, antifungal azoles, macrolide antibiotics, niacin, fibrates> 1 quart grapefruit juice/day or nefazodone
- •Patients with creatinine > 2.0
- •Patients with known malignancy
- •Ejection Fraction < 25%
- •No coronary care unit patients
- •No outpatients
研究组 & 干预措施
Simvastatin
Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
干预措施: Simvastatin (Drug)
Placebo
Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Serum High Sensitivity C-Reactive Protein (hsCRP)
时间窗: baseline, within 24 hours post percutaneous coronary intervention
The hsCRP test evaluates vascular inflammation. People with higher hsCRP values have the highest risk of cardiovascular disease, and those with lower values have less of a risk. The American Heart Association and U.S. Centers for Disease Control and Prevention have defined risk groups as follows: Low risk: less than 1.0 mg/L Average risk: 1.0 to 3.0 mg/L High risk: above 3.0 mg/L
次要结局
- Change in Endothelial Peripheral Arterial Tomography (EndoPAT) Score After PCI(baseline, within 24 hours post percutaneous coronary intervention)