Back to resultsNOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial
Primary Purpose
Myocardial Ischemia
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
intramyocardial delivery of either VEGF165 or placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring angiogenesis, VEGF
Eligibility Criteria
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
Sites / Locations
- University of Alberta
- Victoria Heart Institute Foundation
- Sunnybrook Health Sciences Centre
- St. Michael's Hospital
- Mount Sinai
- Montreal Heart Institute
- Institute de Cardiologie, Hopital Laval
Outcomes
Primary Outcome Measures
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
symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00143585
Brief Title
NOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial
Official Title
Multicentre, Randomized,Double Blind,Placebo Controlled Trial of Myocardial Angiogenesis Using VEGF165, Intramyocardial Gene Delivery in Patients With Severe Angina
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Unity Health Toronto
4. Oversight
5. Study Description
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
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 medications who are not amenable to or not ideal candidates for conventional revascularization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
angiogenesis, VEGF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
intramyocardial delivery of either VEGF165 or placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duncan J. Stewart, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Victoria Heart Institute Foundation
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6R5
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4P 2K2
Country
Canada
Facility Name
Mount Sinai
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Institute de Cardiologie, Hopital Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
12. IPD Sharing Statement
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NOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial
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