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

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ClinicalTrials.gov Identifier: NCT00143585
Recruitment Status : Unknown
Verified July 2008 by St. Michael's Hospital, Toronto.
Recruitment status was:  Active, not recruiting
First Posted : September 2, 2005
Last Update Posted : July 25, 2008
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Procedure: intramyocardial delivery of either VEGF165 or placebo Phase 2 Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multicentre, Randomized,Double Blind,Placebo Controlled Trial of Myocardial Angiogenesis Using VEGF165, Intramyocardial Gene Delivery in Patients With Severe Angina
Study Start Date : June 2002
Estimated Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143585


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada, V8R 6R5
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M4P 2K2
Mount Sinai
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Institute de Cardiologie, Hopital Laval
Quebec City, Quebec, Canada, G1V4G5
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Duncan J. Stewart, MD St. Michael's Hospital, Toronto
More Information

ClinicalTrials.gov Identifier: NCT00143585     History of Changes
Other Study ID Numbers: 02-065
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: July 25, 2008
Last Verified: July 2008

Keywords provided by St. Michael's Hospital, Toronto:
angiogenesis
VEGF

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases