NOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial
- Conditions
- Myocardial Ischemia
- Registration Number
- NCT00143585
- Lead Sponsor
- Unity Health Toronto
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Canadian Cardiovascular Class III-IV angina despite treatment with maximal medical therapy
- LVEF>20%
- Ischemic defects on myocardial stress SPECT imaging
- NYHA>2
- 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
- LV thrombus visualized by either echocardiography or contrast LV angiogram
- Other severe concurrent illnesses
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events
Trial Locations
- Locations (7)
Victoria Heart Institute Foundation
🇨🇦Victoria, British Columbia, Canada
Institute de Cardiologie, Hopital Laval
🇨🇦Quebec City, Quebec, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Mount Sinai
🇨🇦Toronto, Ontario, Canada