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临床试验/NCT00147797
NCT00147797已完成不适用

Influence of Pravastatin on Carotid Artery Structure and Function in HIV-infected Patients Under Antiretroviral Therapy

Saint Antoine University Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2003年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
1

研究概览

简要总结

The advent of new antiretroviral agents, in particular Highly Active Antiretroviral Therapy (HAART), spectacularly reduced HIV-associated morbidity and mortality. However, new complications have appeared in HIV-infected patients treated by with HAART such as dyslipidemia, insulin resistance, diabetes mellitus, and related cardiovascular complications including acute coronary syndromes, peripheral vascular disease, and stroke have been reported.

A linear association has been proved between increased intima-media thickness of the common carotid artery (CCA-IMT), aortic stiffness (pulse wave velocity [aPWV]) and incidence of cardiovascular events suggesting that IMT and aPWV could be considered as an early marker of atherosclerosis. The progression of IMT has been shown to be predictive of cardiovascular events. Case control and longitudinal studies but not all have suggested an increase CCA-IMT in HIV-infected patients under HAART compared with non-HIV infected patients with different progression.

The aim of this study was to examine the effects of pravastatin on CCA-IMT and aortic stiffness in dyslipidemic HIV-infected patients receiving HAART by using a high-resolution echotracking system.

Patients in the pravastatin group were consecutively recruited in four department of infectious diseases if they fulfilled the following criteria : (1) HIV-infected treated with HAART for > 12 months 2) with dyslipidemia, defined as fasting serum LDL cholesterol > 160 mg/dL before initiation of pravastatin, (3) treated with pravastatin > 12 months and one more coronary risk factor. The patients in the control group were selected consecutively in the same departments among 1) HIV-infected patients treated with HAART > 12 months 2) fasting serum LDL cholesterol > 160 mg/dL 3) without lipid-lowering drugs and one more coronary risk factor. Cases and control patients were matched for age, gender and tobacco consumption.

Using data from Mercie et al., inclusion of 42 patients in pravastatin and control groups was the minimum sample size needed for detection of a 6.5% difference in CCA-IMT, in a two-sided test (a = 0.05, b = 0.20).

The protocol of the study, sponsored by the French Society of Cardiology was approved by the Committee for the Protection of Human Subjects in Biomedical Research of Pitié-Salpétrière University hospital in Paris. Written informed consent to participate in the study was obtained from each patient.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

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

入选标准

  • HIV-infected patients treated with HAART for > 12 months
  • With dyslipidemia, defined as LDL cholesterol > 160 mg/dL before initiation of statin
  • Treated with pravastatin > 12 months and one more coronary risk factor. The patients in the control group were selected consecutively in the same departments among
  • HIV-infected patients treated with HAART > 12 months
  • LDL cholesterol > 160 mg/dL
  • Without lipid-lowering drugs and one more coronary risk factor. Cases and control patients were matched for age, gender and tobacco consumption.

排除标准

  • Patients with history of coronary artery disease, peripheral artery disease, endarterectomy, aortic dissection

研究者

发起方
Saint Antoine University Hospital
申办方类型
Other

研究点 (1)

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