Multicentre, Randomized,Double Blind,Placebo Controlled Trial of Myocardial Angiogenesis Using VEGF165, Intramyocardial Gene Delivery in Patients With Severe Angina
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Myocardial Ischemia
- Sponsor
- Unity Health Toronto
- Enrollment
- 120
- Locations
- 7
- Primary Endpoint
- Myocardial perfusion-stress/ rest scores(SRS),changes in summed stress scores(SSS)from baseline to 12 weeks follow up between placebo and VEGF treated groups. This analysis will be repeated at 6 months
- Last Updated
- 17 years ago
Overview
Brief Summary
To demonstrate the clinical efficacy and safety of vascular endothelial growth factor(VEGF165)when delivered by direct myocardial injection through the NOGA navigational catheter to improve myocardial perfusion in patients with severe angina pectoris for whom conventional PCI or CABG are either not possible or not ideal.Secondary objective will be to determine the effects of VEGF gene therapy on angina symptoms, patient perceived quality of life and exercise capacity
Detailed Description
A multicentre, double blind, placebo controlled trial to assess efficacy of VEGF and promote myocardial angiogenesis in patients with CCS III-IV angina symptoms,treated with maximal anti anginal medications who are not amenable to or not ideal candidates for conventional revascularization.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Canadian Cardiovascular Class III-IV angina despite treatment with maximal medical therapy
- •LVEF\>20%
- •Ischemic defects on myocardial stress SPECT imaging
Exclusion Criteria
- •History of or diagnosis of age related macular degeneration, retinopathy
- •Atrial fibrillation
- •Primary valvular heart disease
- •Evidence of or known history of cancer with in past 10 yea
- •Uncontrolled hypertension
- •Liability to receive dipyridamole
- •History or diagnosis of rheumatoid arthritis
- •Recent MI(within 4 weeks)
- •Important ilio-femoral peripheral vascular disease, limiting catheter access
- •History of unexplained gastrointestinal hemorrhage with the past 5 years
Outcomes
Primary Outcomes
Myocardial perfusion-stress/ rest scores(SRS),changes in summed stress scores(SSS)from baseline to 12 weeks follow up between placebo and VEGF treated groups. This analysis will be repeated at 6 months
Secondary Outcomes
- symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events