NOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial
Multicentre, Randomized,Double Blind,Placebo Controlled Trial of Myocardial Angiogenesis Using VEGF165, Intramyocardial Gene Delivery in Patients With Severe Angina
1 other identifier
interventional
120
1 country
7
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2002
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJuly 25, 2008
July 1, 2008
September 1, 2005
July 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events
Interventions
Eligibility Criteria
You may qualify if:
- Canadian Cardiovascular Class III-IV angina despite treatment with maximal medical therapy
- LVEF\>20%
- Ischemic defects on myocardial stress SPECT imaging
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Alberta
Edmonton, Alberta, T6G 2B7, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 6R5, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M4P 2K2, Canada
Mount Sinai
Toronto, Ontario, M5G 1X5, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Institute de Cardiologie, Hopital Laval
Québec, Quebec, G1V4G5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Duncan J. Stewart, MD
Unity Health Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 2, 2005
Study Start
June 1, 2002
Study Completion
June 1, 2007
Last Updated
July 25, 2008
Record last verified: 2008-07