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

Unity Health Toronto120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Myocardial Ischemia

Interventions

intramyocardial delivery of either VEGF165 or placeboPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (7)

University of Alberta

Edmonton, Alberta, Canada

Victoria Heart Institute Foundation

Victoria, British Columbia, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

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

Data from ClinicalTrials.gov

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