NCT01925352Unknown1 期
Phase 2 Study of Adenovirus Hepatocyte Growth Factor for Treatment of Ischemic Heart Disease
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of participants with death,new myocardial infarction or stroke
研究概览
简要总结
To explore the safety and efficiency of adenovirus-hepatocyte growth factor(Ad-HGF) treatment in ischemic heart disease.
详细描述
- Ischemic heart disease refers to a group of closely related syndromes by an imbalance between the myocardial oxygen demand and the blood supply.
- Gene therapy offers an attractive alternative to current pharmacologic therapies and may be beneficial in refractory disease. Gene therapy with hepatocyte growth factor induces angiogenesis, decreases apoptosis and leads to protection in the ischemic heart. In this study, we mainly explore the safety and effects of adenovirus hepatocyte growth factor for the treatment of ischemic heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •person with ischemic heart disease;
- •Male or female of 20 to 70 years old;
- •No blood perfusion detected in some area of heart using Single-Photon Emission Computed Tomography(SPECT) or Magnetic Resonance Imaging(MRI)
- •two or more than two coronary arteries lesions were detected using coronary artery angiography and at least one coronary artery are un-suitable for percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG)；Or patients refuse to perform PCI or CABG
- •LVEF is ≤45%;
- •Patients must sign approved informed consent.
排除标准
- •Acute myocardial infarction occured within one week
- •CABG performed within 6 months or PCI performed within 3 months
- •Patients with systemic active infection
- •Blood alanine aminotransferase (ALT)>135mmol/L or blood crea(Cr)>200umol/L or patients with chronic obstructive pulmonary disease (COPD)
- •patients with obvious bleeding tendency and blood disease
- •patients with malignant tumor or end-stage disease
- •patient anticipated life expectancy is less than 12 months
- •patient recently attended test drugs or other device research
研究组 & 干预措施
Ad-HGF
Experimental
5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection in patients with ischemic heart disease into five left ventricular sites once.
干预措施: Ad-HGF (Drug)
结局指标
主要结局
Number of participants with death,new myocardial infarction or stroke
时间窗: 6 months after treatment
次要结局
- left ventricular ejection fraction (LVEF)(6 months after treatment)
研究者
zhijian yang
Professor
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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