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临床试验/NCT01178710
NCT01178710已完成不适用

The Cardiac Protective Effect of Simvastatin on Cardiac Surgery: a Double Blind, Randomised Clinical Trial

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
151
试验地点
1
主要终点
plasma troponin T level

研究概览

简要总结

It is well know that statins have been used to low cholesterol to prevent and treat coronary artery disease for many years. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. However, some results were controversial. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalent. Thus, the investigators are trying to see whether statins can protect heart injury during cardiac surgery in Chinese. Part of patients will receive statin treatment and part of will not before surgery in the study. Both patients' heart function will be measured and compared after surgery to determine whether statins can protect heart injury during heart surgery.

详细描述

Cardiac function is crucial for cardiac surgery. The mortality remains very high in patients with poor cardiac function preoperation, long surgical time, complicate or difficult surgical procedure or uncompleted corrected malformation currently. Thus, it is necessary to search other approaches to improve cardiac function for cardiac surgery patients in order to increase the success, decrease complication and mortality in cardiac surgery.

Although statin has been used to low cholesterol to prevent and treat coronary artery disease for many years, it has been reported that statin could protect endothelial function and cardiac function in coronary artery bypass graft. However, some results were controversy. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalence.Thus, it is necessary to perform a double blind, randomised clinical trial in China to determine whether statin can protect heart injury during heart surgery in China and what's its mechanism.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cyanotic congenital heart disease
  • noncyanotic congenital heart disease with pulmonary hypertension
  • Heart valve disease,
  • other heart and great artery diseases need heart or great artery surgery

排除标准

  • Coronary artery disease
  • under 10-year-old.
  • noncyanotic congenital heart disease without pulmonary hypertension
  • poor liver function such AST elevated,Hepatitis
  • Gestation women and Breast-feeding women

研究组 & 干预措施

treatment

Experimental

干预措施: Simvastatin (Drug)

结局指标

主要结局

plasma troponin T level

时间窗: within the first 7 days after surgery

The investigator will measure the plasma troponin T level in several time points before and after surgery in each patient.

次要结局

  • the index of B ultrasound on heart(one year after surgery)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jing-song Ou

associate chief

Sun Yat-sen University

研究点 (1)

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