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

Unity Health Toronto

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Myocardial Ischemia

Treatments: Procedure: intramyocardial delivery of either VEGF165 or placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00143585

02-065

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind