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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by St. Michael's Hospital, Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00143585
First received: September 1, 2005
Last updated: July 24, 2008
Last verified: July 2008
History of Changes
  Purpose

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 Intervention Phase
Myocardial Ischemia
 Procedure: intramyocardial delivery of either VEGF165 or placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

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

Estimated Enrollment: 120
Study Start Date: June 2002
Estimated Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
St. Michael's Hospital
Toronto, Ontario, Canada, M4P 2K2
Mount Sinai
Toronto, Ontario, Canada, M5G 1X5
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
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

No publications provided

ClinicalTrials.gov Identifier: NCT00143585     History of Changes
Other Study ID Numbers: 02-065
Study First Received: September 1, 2005
Last Updated: July 24, 2008
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on May 23, 2013