Status:
COMPLETED
EndocardialVascularEndothelialGrowth Factor D(VEGF-D)Gene Therapy for the Treatment of Severe Coronary Heart Disease
Lead Sponsor:
Kuopio University Hospital
Collaborating Sponsors:
University of Eastern Finland
Conditions:
Angina Pectoris
Myocardial Infarction
Eligibility:
All Genders
30-80 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of catheter mediated endocardial adenovirus VEGF-D gene therapy in patients with severe coronary heart disease.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01002430
Start Date
January 10 2010
End Date
June 15 2015
Last Update
March 8 2018
Active Locations (1)
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1
Kuopio University Hospital
Kuopio, Finland