EUCTR2015-002929-19-NL进行中（未招募）1 期
Stem Cell therapy in IschEmic Non-treatable Cardiac disease - SCIENCE - SCIENCE
Department of Cardiology, Rigshospitalet0 个研究点目标入组 139 人开始时间: 2015年11月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 139
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 30 to 80 years of age
- •2. Signed informed consent
- •3. Chronic stable ischemic heart disease
- •4. Heart failure (NYHA II-III)
- •5. LVEF =45%
- •6. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm
- •7. Maximal tolerable heart failure medication
- •8. Medication unchanged two months prior to inclusion
- •9. No option for percutaneous coronary intervention (PCI) or coronary
- •artery bypass graft (CABG)
- •10. Patients who have had PCI or CABG within six months of inclusion
- •must have a new angiography less than one month before inclusion or at
- •least four months after the intervention to rule out early restenosis
- •11. Patients cannot be included until three months after implantation of
- •a cardiac resynchronisation therapy device
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 79
排除标准
- •Exclusion criteria
- •1. Heart Failure (NYHA I or IV)
- •2. Acute coronary syndrome with elevation of CKMB or troponins,
- •stroke or transitory cerebral ischemia within six weeks of inclusion
- •3. Other revascularisation treatment within four months of treatment
- •4. If clinically indicated the patient should have a coronary angiography
- •before inclusion
- •5. Moderate to severe aortic stenosis (valve area < 1.3 cm2) or
- •valvular disease with option for surgery.
- •6. Diminished functional capacity for other reasons such as: obstructive
- •pulmonary disease (COPD) with forced expiratory volume (FEV) <1
- •L/min, moderate to severe claudication or morbid obesity
- •7. Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia
- •(leucocytes < 2 109/L), leucocytosis (leucocytes >14 109/L) or
- •thrombocytopenia (thrombocytes < 50 109/L)
- •8. Anticoagulation treatment that cannot be paused during cell
- •9. Patients with reduced immune response
- •10. History with malignant disease within five years of inclusion or
- •suspected malignity – except treated skin cancer other than melanoma
- •11. Pregnant women
- •12. Other experimental treatment within four weeks of baseline tests
- •13. Participation in another intervention trial
研究者
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