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临床试验/EUCTR2011-005435-98-PL
EUCTR2011-005435-98-PL
进行中(未招募)
1 期

A randomized, prospective, double-blind study with placebo to evaluate the efficacy of treatment of patients with angina resistant to pharmacological treatment and induced myocardial ischemia without possibility of effective revascularization, using isolated from bone marrow, autological CD133+ cells administered directly into the muscle of left ventricle. REGENT-VSEL Study. - REGENT VSE

Slaski Uniwersytet Medyczny w Katowicach0 个研究点2012年2月24日

概览

阶段
1 期
干预措施
未指定
疾病 / 适应症
Stable angina pectoris CCS II-IV
发起方
Slaski Uniwersytet Medyczny w Katowicach
状态
进行中(未招募)
最后更新
9年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2012年2月24日
结束日期
待定
最后更新
9年前
研究类型
Interventional clinical trial of medicinal product
性别
All

研究者

发起方
Slaski Uniwersytet Medyczny w Katowicach

入排标准

入选标准

  • 1\.Stable angina CCS II\-IV despite maximum pharmacotherapy for at least 2 weeks since last medications change
  • 2\.Presence of \= 1 miocardium segment with ischemia features in Tc\-99m SPECT
  • 3\.Patients disqualified from revascularization procedures by heart\-team
  • 4\.Patient age \> 18 and \< 75 year old
  • 5\.Patient must provide written informed consent for participation in study
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 30
  • F.1\.3 Elderly (\>\=65 years) yes

排除标准

  • 1\.acute coronary syndrome in less than 6 months prior to enrollment
  • 2\.heart failure NYHA III\-IV
  • 3\.LVEF\<35%
  • 4\.presence of intracardiac thrombus (echocardiography confirmed), massive calcification of the aortic valve and left ventricular aneurysm
  • 5\.status after cardioverter defibrillator or cardiac stimulator implantation
  • 6\.allergy to contrast agents
  • 7\.malignancy in medical interview
  • 8\.HIV, HBV, HCV infection
  • 9\.status associated with life expectancy less than 6 months
  • 10\.bleeding diathesis

结局指标

主要结局

未指定

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