Efficacy of gene therapy in the treatment of patients with symptomatic angina pectoris in spite of optimal medical therapy and which cannot be treated with balloon angioplasty or bypass surgery.
- Conditions
- Refractory anginaMedDRA version: 20.0Level: LLTClassification code 10064262Term: Refractory angina pectorisSystem Organ Class: 100000011625Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-000789-31-FI
- Lead Sponsor
- Kuopio University Hospital Heart Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of the study is to evaluate the safety and efficacy of catheter mediated AdVEGF-D regenerative gene transfer in patients with refractory angina to whom revascularization cannot be performed. ;Secondary Objective: The study also investigates the effect of VEGF-D-therapy on myocardial perfusion, patients' symptoms, quality of life and safety of treatment.;Primary end point(s): 1. Improvement of functional capacity using 6-minute walking test<br>2. Improvement of symptoms assessed by Canadian Cardiovascular Society (CCS) class;Timepoint(s) of evaluation of this end point: 1. After 6 months follow-up<br>2. After 6 months follow-up
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Improvement of functional capacity using 6-minute walking test<br>2. Improvement of symptoms assessed by Canadian Cardiovascular Society (CCS) class<br>3. Increase in myocardial perfusion;Timepoint(s) of evaluation of this end point: 1. After 12 months follow-up<br>2. After 12 months follow-up<br>3. After 6 months follow-up