NOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicentre, Randomized,Double Blind,Placebo Controlled Trial of Myocardial Angiogenesis Using VEGF165, Intramyocardial Gene Delivery in Patients With Severe Angina

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Procedure: intramyocardial delivery of either VEGF165 or placebo


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: intramyocardial delivery of either VEGF165 or placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VEGF, angiogenesis