In vivo molecular imaging of angiogenesis after VEGF-D gene therapy

Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET0 个研究点目标入组 30 人开始时间: 2018年4月26日最近更新: 2023年8月21日

适应症

试验速览

暂无简介。

•-informed consent signed
•-age > 30 but < 85 years
•-significant angina pectoris (CCS 2-3) despite of optimal medication
•-significant stenosis (> 60%) in coronary angiography (< 12 months)
•-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)
•-angina pectoris or equivalent symptoms in the 6-minute walking exercise test
•-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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•-women in fertile age
•-diabetes mellitus with severe complications such as proliferative diabetic retinopathy or nephropathy with renal insufficiency (see below)
•-clinically significant anemia (hemoglobin count < 120 mg/l in male, < 110 mg/l in female; hematocrit < 0.36)
•-leukopenia (b-leukocyte count < 3.0x109/l), leukocytosis (b-leukocyte count > 12.0x109/l) or thrombocytopenia (b-thrombocyte count < 100x109/l)
•-renal insufficiency (P-creatinine > 160 mg/l)
•-liver insufficiency (P-alanine aminotransferase or P-alkaline phosphatase over 2 x normal)
•-hematuria of unknown origin
•-severe hypertension (systolic blood pressure > 200 mmHg or diastolic blood pressure > 110 mmHg) or significant hypotension (systolic blood pressure < 90 mmHg)
•-significant obesity (BMI > 35)
•-acute infection
•-immunosuppressive medication
•-significant impairment of left ventricular function (EF < 25%)
•-symptomatic congestive heart failure (NYHA 3-4)
•-hemodynamically significant (grade 3-4/4) aortic or mitral regurgitation or other heart disease needing surgery
•-recent (< 3 months) acute coronary syndrome or myocardial infarction (elevated CK-MB or cardiac troponin), PCI, CABG or TIA/stroke
•-current or suspected malignancy

发起方

Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET