Status:
UNKNOWN
NOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial
Lead Sponsor:
Unity Health Toronto
Conditions:
Myocardial Ischemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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...
Detailed 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 medic...
Eligibility Criteria
Inclusion
- Canadian Cardiovascular Class III-IV angina despite treatment with maximal medical therapy
- LVEF\>20%
- Ischemic defects on myocardial stress SPECT imaging
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00143585
Start Date
June 1 2002
End Date
June 1 2007
Last Update
July 25 2008
Active Locations (7)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
2
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada, V8R 6R5
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
4
St. Michael's Hospital
Toronto, Ontario, Canada, M4P 2K2