Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- The main objective of this study is to estimate if the measure of CEC and PEC possesses a meaning forecast towards the arisen of complications post procedure.
研究概览
简要总结
In stent restenosis and myocardial infarction are have been linked the balance between injury and healing of the endothelium These processes can be measured respectively using the number of circulating endothelial cells and endothelial progenitor cells. We therefore aimed to evaluate the relationship between the balance of injury and healing of the endothelium at the time of PCI and major adverse cardiovascular events including death, myocardial infarction and target lesion revascularization at 6 and 12 months follow-up.
详细描述
Following percutaneous coronary intervention with bare metal stents, the rate of major adverse cardiovascular events including death, myocardial infarction and target lesion revascularization is high ranging between 20 and 25%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years old
- •Scheduled for PCI
- •Clinical evidence of ischemic heart disease and/or abnormal functional study
- •New coronary artery lesion >50%
- •treatment with bare metal stent planned
- •Informed consent explained, red, understood and signed by the patient
排除标准
- •Pregnancy, birth or lactation period <6 months ago
- •Women of childbearing age who do not intend to use accepted anticonceptive measures or who wish to get pregnant
- •Left ventricular ejection fraction <30%
- •Acute coronary syndrome (ST-elevation or not) in the past month
- •Planned drug eluting stent implantation
- •Lesion in arterial or venous bypass or anastomosis with coronary
- •Severe renal insufficiency (creatinine clearance <30 mL/')
- •Severe hepatic insufficiency
- •Systemic inflammatory pathology of any kind
- •Hematologic or other malignancy, prior radio- or chemotherapy
- •Use of corticosteroïds or immune suppression therapy
- •Contrast allergy
- •Life expectancy <1 year
- •Participation in other clinical study which has not ended yet
研究组 & 干预措施
1
Data private hospitals, angioplasty, sampling of blood
干预措施: Data private hospitals, angioplasty, sampling of blood (Other)
结局指标
主要结局
The main objective of this study is to estimate if the measure of CEC and PEC possesses a meaning forecast towards the arisen of complications post procedure.
时间窗: 36 months
次要结局
- To determine the relation between these endothelial biomarkers and the other usual parameters forecast complications post-angioplasty(36 months)