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Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention

2012年10月9日 更新者:Mayo Clinic

The Effect of Acute Statin Treatment on Inflammation and Peripheral Arterial Tone in Patients Undergoing Percutaneous Coronary Intervention.

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

57

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients undergoing PCI/angiography
  • No previously known side effects of statins
  • Patients who sign an informed consent
  • Age > 18 years old

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器:Simvastatin
Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
其他名称:
  • Zocar
安慰剂比较:Placebo
Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Serum High Sensitivity C-Reactive Protein (hsCRP)
大体时间: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

baseline, within 24 hours post percutaneous coronary intervention

次要结果测量

结果测量
措施说明
大体时间
Change in Endothelial Peripheral Arterial Tomography (EndoPAT) Score After PCI
大体时间:baseline, within 24 hours post percutaneous coronary intervention

The EndoPAT is a noninvasive test that involves putting probes on the index fingers of both hands and evaluating the blood flow to one hand before and after inflating a blood pressure cuff on one arm, temporarily reducing blood flow to the fingers. The finger sensor on the affected arm will now show no blood flow, while the sensor on the opposite index finger will continue to display your normal blood flow level. After several minutes, the blood pressure cuff is released, allowing blood to flow back into the affected lower arm. If the finger sensor on the affected arm shows a rush of blood, the blood vessels are functioning normally. If the blood flow return is sluggish, however, the blood vessels are unhealthy.

The results are reported as the "Endoscore" (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart.

baseline, within 24 hours post percutaneous coronary intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2002年11月1日

初级完成 (实际的)

2011年4月1日

研究完成 (实际的)

2011年4月1日

研究注册日期

首次提交

2007年12月22日

首先提交符合 QC 标准的

2008年1月7日

首次发布 (估计)

2008年1月8日

研究记录更新

最后更新发布 (估计)

2012年11月8日

上次提交的符合 QC 标准的更新

2012年10月9日

最后验证

2012年10月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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