NOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial
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ClinicalTrials.gov Identifier: NCT00143585
Recruitment Status : Unknown
Verified July 2008 by St. Michael's Hospital, Toronto. Recruitment status was: Active, not recruiting
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
Condition or disease
Procedure: intramyocardial delivery of either VEGF165 or placebo
Phase 2Phase 3
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.
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 :
symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Canadian Cardiovascular Class III-IV angina despite treatment with maximal medical therapy
Ischemic defects on myocardial stress SPECT imaging
History of or diagnosis of age related macular degeneration, retinopathy
Primary valvular heart disease
Evidence of or known history of cancer with in past 10 yea
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