EndocardialVascularEndothelialGrowth Factor D(VEGF-D)Gene Therapy for the Treatment of Severe Coronary Heart Disease

Launched by KUOPIO UNIVERSITY HOSPITAL · Oct 26, 2009

Keywords

ClinConnect Summary

Study objective(s):

The purpose of the study is to evaluate the safety and efficacy of catheter mediated endocardial adenovirus VEGF-D gene transfer in patients with severe coronary heart disease to whom revascularisation cannot be performed ("no option -patients"). The primary objective is safety of the gene therapy and the secondary objective is the efficacy of gene therapy to improve myocardial perfusion as measured by MRI, PET and left ventricular function as measured by echocardiography as well as to improve functional status as measured by bicycle ergometer test. Quality of life will...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • informed consent signed,
• • age between 30 and 80 years,
• • significant angina pectoris (CCS II-III) despite of maximal medication,
• • significant stenosis in coronary angiography (stenosis \> 60 %),
• • contraindication to coronary angioplasty or by pass operation (diffuse or distal stenosis,
• • chronic total occlusion,
• • vessels with difficult anatomy,
• • stenosis with severe calcifications,
• • stenosis in small vessels (\< 2.5 mm)),
• • reversible myocardial perfusion defects detected by pharmacological adenosine or dobutamine assisted perfusion MRI,
• • angina pectoris or ischemic ST-depression (\> 1 mm) in the exercise test,
• • left ventricle wall \> 8 mm detected by transthoracal echocardiography (treatment area).
• Exclusion Criteria:
• • women in fertile age,
• • patients with type 1 diabetes mellitus or severe end-stage type 2 diabetes mellitus,
• • diabetic retinopathy,
• • atrial fibrillation,
• • 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 (s-creatinine \> 160mg/l),
• • liver insufficiency (s-alanine amino transferase and s-alcaline phosphatase over 2 x normal),
• • haematuria of unknown origin,
• • severe hypertension (systolic blood pressure \> 200 mmHg or diastolic blood pressure \> 110 mmHg) or significant hypotension (systolic blood pressure \< 90mmHg),
• • significant obesity (BMI \> 35),
• • cardiac pacemaker,
• • acute infection,
• • immunosuppressive medication,
• • significant impairment of the left ventricular function (EF \< 25% in TTE or CO \< 2 l in MRI),
• • congestive heart failure,
• • haemodynamically significant (gradus 3-4/4) aortic regurgitation or other heart disease needing surgery,
• • recent ( \< 6 weeks) acute coronary syndrome or myocardial infarction (elevated CK-MB or cardiac troponin),
• • PCI or CABG or TIA/stroke,
• • previous or current malignancy.