Cilostazol Enhances the Number and Functions of Circulating Endothelial Progenitor Cells and Collateral Formation Assessed by Dual-energy 128-row CT Angiography Mediated Through Multiple Mechanisms in Patients With Mild-to-moderate PAOD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Circulating EPCs Number
研究概览
简要总结
- The number and function of circulating endothelial progenitor cells (EPCs) are inversely associated with coronary risk factors and atherosclerotic diseases such as PAOD.
- This double-blind, randomized, placebo-controlled trial to evaluate the effects of cilostazol on human early EPCs and angiogenesis as well as the potential mechanisms of action in patients with mild-to-moderate PAOD.
详细描述
-
titration of drugs
-
run-in period: eligible subjects are screened and baseline blood samples are obtained
-
study period: 12 weeks
- 24 subjects with cilostazol and 20 subjects with dummy placebo
- On the first day after the end of the study period, the follow-up data are obtained by the same procedure
- blood sampling and measurement of serum biomarkers
- obtained from peripheral veins in all study subjects at the run-in period and the end of the treatment period of the study
- sent for isolation, cell culture, and assays of human EPCs
- also stored for enzyme-linked immunosorbent assay (Stromal cell derived factor-alfa1, adiponectin, soluble thrombomodulin, vascular endothelial growth factor)
-
assays of human EPCs
-
colony formation by EPCs
-
quantification of EPCs and apoptotic endothelial cells
-
chemotactic motility, proliferation/viability and apoptosis assays
-
collateral vessels formation and distal run-off assessed by dual-energy multi-slice computed tomography angiography
-
echocardiographic examinations to evaluate left ventricular functions
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ankle-brachial index (ABI) less than 0.9 in one or both legs but no obvious symptoms of intermittent claudication
排除标准
- •obvious symptoms of intermittent claudication
- •severe PAD (Fontaine grading > 3) or critical limb ischemia in at least one leg
- •severe liver dysfunction (transaminases >10 times of upper normal limit, history of liver cirrhosis, or hepatoma)
- •> stage 4 chronic kidney disease (end-stage renal disease with chronic dialysis not excluded)
- •left ventricular ejection fraction <50% by echocardiography
- •documented active malignancy
- •chronic inflammatory disease
- •planned coronary intervention or endovascular therapy or bypass surgery within 3 months
- •known drug allergy history for cilostazol
- •current use of cilostazol or any other cAMP-elevator
- •premenopausal women
研究组 & 干预措施
Cilostazol
One tablet (100 mg) twice per day for 12 weeks
干预措施: Cilostazol (Drug)
Dummy Placebo
One tablet twice per day for 12 weeks
干预措施: Dummy Placebo (Drug)
结局指标
主要结局
Circulating EPCs Number
时间窗: 3 months
Peripheral blood mononuclear cells (one million cells in each) are suspended in 100 µL phosphate-buffered saline and incubated for 30 min with monoclonal antibodies against human peridinin chlorophyll protein-conjugated cluster of differentiation antigen-45, phycoerythrin-conjugated anti-human cluster of differentiation antigen-34 antibody and anti-human kinase insert domain receptor (KDR) antibody conjugated with Alexa Flour 647. Cells are washed and analyzed on a FACSCalibur flow cytometer with 100,000 events in the lymphocyte gate. EPCs, which are defined as negative for cluster of differentiation antigen-45 and positive for cluster of differentiation antigen-34 and KDR. Based on the peripheral blood mononuclear cell counts, the absolute number of circulating EPCs/µL is calculated.
次要结局
- Colony Formation by EPCs(3 months)