EUCTR2017-000789-31-FI进行中（未招募）1 期
Clinical development and proof of principle testing of new regenerative VEGF-D therapy for cost-effective treatment of refractory angina. A phase II randomized, double-blinded, placebo-controlled study. - ReGenHeart
Kuopio University Hospital Heart Center0 个研究点目标入组 180 人开始时间: 2017年7月20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
- 180
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. Informed consent signed
- •2. Age > 30 but = 85 years
- •3. Significant angina pectoris (CCS 2-3) despite of optimal medication
- •4. Significant stenosis (= 60%) in coronary angiography (= 6 months)
- •5. Contraindication to CABG or PCI due to diffuse or distal stenosis, chronic total occlusion, vessels with difficult anatomy, stenosis with severe calcifications and stenosis in small vessels (<2.5 mm)
- •7. Angina pectoris or equivalent symptoms in the 6-minute walking exercise test
- •8. left ventricle wall = 8 mm detected by transthoracic echocardiography (treatment area)
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •1. Women in fertile age
- •2. Diabetes mellitus with severe complications such as proliferative diabetic retinopathy or nephropathy with renal insufficiency (see below)
- •3. Clinically significant anemia (hemoglobin count < 120 mg/l in male, < 110 mg/l in female; hematocrit < 0.36)
- •4. Leukopenia (b-leukocyte count < 3.0x109/l), leukocytosis (b-leukocyte count > 12.0x109/l) or thrombocytopenia (b-thrombocyte count < 100x109/l)
- •5. Renal insufficiency (P-creatinine > 160 mg/l)
- •6. Liver insufficiency (P-alanine aminotransferase or P-alkaline phosphatase over 2 x normal)
- •7. Hematuria of unknown origin
- •8. Severe hypertension (systolic blood pressure > 200 mmHg or diastolic blood pressure > 110 mmHg) or significant hypotension (systolic blood pressure < 90 mmHg)
- •9. Significant obesity (BMI > 35)
- •10. Acute infection
- •11. Immunosuppressive medication
- •12. Significant impairment of left ventricular function (EF < 25%)
- •13. Symptomatic congestive heart failure (NYHA 3-4)
- •14. Hemodynamically significant (grade 3-4/4) aortic or mitral regurgitation or other heart disease needing surgery
- •15. Recent (< 6 weeks) acute coronary syndrome or myocardial infarction (elevated CK-MB or cardiac troponin), PCI, CABG or TIA/stroke
- •16. Current or suspected malignancy
研究者
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