ACTRN12611000219987撤回2 期
A study of the effect of direct endomyocardial injection of autologous bone marrow cells on left ventricular ejection function in patients with end-stage ischaemic heart failure.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Age 18 -80 years.
- •CCS classification II-IV angina and/or NYHA classification II-III heart failure symptoms.
- •Received stable and best” cardiac medical therapy including diuretics, long-acting nitrates, beta-blocker, and angiotensin-converting enzyme inhibitors without control of symptoms.
- •Not suitable for conventional revascularization (due to diffuse disease, chronic total occlusion, lack of graftable vessels or any combination thereof).
- •LVEF <40% by echocardiography.
- •Recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of Coronary Artery Disease (CAD) that is not amenable to standard revascularization procedures.
- •Serum creatinine less than 250mmol/L, normal liver function, and normal blood count: white blood cell (WBC) count, granulocytes; platelet count, haemolglobin (Hb).
- •Reversible perfusion defect on SPECT.
- •Hemodynamically stable.
- •Subject is willing to comply with specified follow-up evaluations.
排除标准
- •Atrial fibrillation.
- •History of syncope or major ventricular arrhythmias such as sustained ventricular tachycardia or ventricular fibrillation.
- •Severe valve disease.
- •Aortic or mitral valve prosthesis.
- •History of cancer in last 5 years.
- •Acute or chronic active sepsis, including human immunodeficiency virus (HIV) positive; hepatitis B or C positive.
- •Left ventricular (LV) wall thickness less than 8 mm in the target territory (by echocardiography or MRI).
- •LV thrombus and/or spontaneous echo-contrast in the LV detected by echocardiography or LV aneurysm.
- •Severe aorto-femoral-iliac disease.
- •Recent heart attack within the last 30 days.
- •Hypertrophic or restrictive cardiomyopathy.
- •Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
研究者
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