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临床试验/NCT01096875
NCT01096875已完成4 期

Assessment of the Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary ByPass Surgery; A Randomized Controlled Trial

Ankara University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Endothelial Progenitor Cells (EPCs) Count (Cells/µl)

研究概览

简要总结

Experimental data have demonstrated favourable effects of statins on endothelial progenitor cell (EPC) mobilization from the bone marrow, and cardiac homing. The purpose of the present prospective randomized controlled trial is to determine the effects of aggressive atorvastatin treatment (40 mg daily 2-weeks prior to surgery) on the number of endothelial progenitor cells (EPCs) after cardiopulmonary bypass by comparing with placebo.

详细描述

Endothelial progenitor cells, a subgroup of hematopoietic stem cells have a significant role in vascular homeostasis. In animal models of ischemia, endothelial progenitor cells are rapidly incorporated into sites of neovascularization, have the potential to induce and augment vasculogenesis/ angiogenesis, prevent cardiomyocyte apoptosis in peri-infarct regions, and reduce adverse remodeling. Treatment with atorvastatin has been shown to increase endothelial progenitor cell count in patients with coronary artery disease. Therefore, we will investigate whether atorvastatin augments the number of endothelial progenitor cells after cardiopulmonary bypass in patients undergoing coronary artery bypass surgery (CABG). Thus, we conducted a randomized double-blind, placebo-controlled, 2-way parallel trial in 60 patients undergoing coronary artery bypass surgery. Patients will receive either 2-week treatment with atorvastatin or placebo prior to surgery. Endothelial progenitor cells will be quantitated by flow cytometric phenotyping obtained from peripheral blood samples. In addition, cardiac markers (CK-MB mass, cardiac troponin-I), biochemical profile, liver function tests, high sensitive C-reactive protein (hsCRP) and coagulation profile will be determined at 4 time points: 1) preoperatively (baseline); 2) 6 hours after the end of cardiopulmonary bypass; 3) 24 hours after surgery; 4) 5th days postoperatively. Clinical, operative characteristics, cardiac markers, high sensitive C-reactive protein and endothelial progenitor cell count will be compared between the groups. Adverse outcomes will also be noted and reported.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective isolated coronary artery bypass surgery with on-pump technique
  • Written informed consent

排除标准

  • Concomitant valve or aortic surgery
  • Left ventricular aneurysm repair
  • Re-operation
  • Emergency surgery
  • History of myocardial infarction within less than 4 weeks
  • Hepatic impairment
  • Chronic renal impairment
  • Drug related side effects (allergy or hypersensitivity)
  • Familial Hyperlipidemia
  • Autoimmune conditions which require steroids

研究组 & 干预措施

Atorvastatin

Active Comparator

Hydroxymethylglutaryl-CoA Reductase Inhibitors

干预措施: Atorvastatin (Drug)

Placebo

Placebo Comparator

Atorvastatin like pill

干预措施: Placebo (Drug)

结局指标

主要结局

Endothelial Progenitor Cells (EPCs) Count (Cells/µl)

时间窗: Postoperative 6th hours

次要结局

  • High Sensitive C-reactive Protein (hsCRP mg/L)(5 days postoperatively)
  • Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively(Change between statin and placebo groups at 30 days postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

A. Ruchan Akar

Professor, Consultant Cardiovascular Surgeon

Ankara University

研究点 (1)

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