NCT01901549Unknown2 期
Renal Denervation in Patients After Acute Coronary Syndrome
Meshalkin Research Institute of Pathology of Circulation1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- cardiovascular death
研究概览
简要总结
This study is aimed to evaluate the effect of renal denervation to decreasing blood pressure and left ventricle remodeling progression in patients after acute coronary syndrome.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute Q negative myocardium infarction (during first 14 days)
- •non stable angina
- •significant stenosis
- •BP > 140/90 torr. during more than 1 year
排除标准
- •absence of arterial hypertension
- •Thrombolysis during previous 24 hours
- •indications for CABG
研究组 & 干预措施
PCI+Renal denervation
Active Comparator
干预措施: Renal denervation (Procedure)
PCI+Renal denervation
Active Comparator
干预措施: Metoprolol (Drug)
PCI+Renal denervation
Active Comparator
干预措施: Lisinopril (Drug)
PCI alone
Active Comparator
干预措施: Metoprolol (Drug)
PCI alone
Active Comparator
干预措施: Lisinopril (Drug)
结局指标
主要结局
cardiovascular death
时间窗: 1 year
myocardium infarction
时间窗: 1 year
stroke
时间窗: 1 year
repeat revascularization
时间窗: 1 year
次要结局
- heart rhythm disturbances(1 year)
- blood pressure changes(1 year)
- CCS and NYHA(1 year)
- intima-media index(1 year)
- IVS thickness(1 year)
- restenosis(1 year)
- diastolic disfunction(1 year)
研究者
研究点 (1)
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