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

July 24, 2008 updated by: Unity Health Toronto

Multicentre, Randomized,Double Blind,Placebo Controlled Trial of Myocardial Angiogenesis Using VEGF165, Intramyocardial Gene Delivery in Patients With Severe Angina

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6R5
        • Victoria Heart Institute Foundation
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai
      • Toronto, Ontario, Canada, M4P 2K2
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Quebec City, Quebec, Canada, G1V4G5
        • Institute de Cardiologie, Hopital Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Duncan J. Stewart, MD, Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion (Anticipated)

June 1, 2007

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

July 25, 2008

Last Update Submitted That Met QC Criteria

July 24, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Ischemia

Clinical Trials on intramyocardial delivery of either VEGF165 or placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe