Assessment of the Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary ByPass Surgery; A Randomized Controlled Trial
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
- 否
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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
干预措施: Atorvastatin (Drug)
Placebo
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
A. Ruchan Akar
Professor, Consultant Cardiovascular Surgeon
Ankara University
