A Phase 2/3 interventional study of intramyocardial delivery of either VEGF165 or placebo in Myocardial Ischemia, sponsored by Unity Health Toronto. Status unknown at 7 sites in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-07-25.
Sponsored by Unity Health Toronto · Phase 2/3, Interventional, and Treatment
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
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.
3,233 studies on the registry are indexed under Myocardial Ischemia; 396 are open to participants now.
This study's enrollment of 120 is close to the median of 120 across 1,895 interventional studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events
This study is status unknown, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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Unity Health Toronto