Overview

This trial is active, not recruiting.

Condition myocardial ischemia
Treatment intramyocardial delivery of either vegf165 or placebo
Phase phase 2/phase 3
Sponsor St. Michael's Hospital, Toronto
Start date June 2002
End date June 2007
Trial size 120 participants
Trial identifier NCT00143585, 02-065

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

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
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Multicentre, Randomized,Double Blind,Placebo Controlled Trial of Myocardial Angiogenesis Using VEGF165, Intramyocardial Gene Delivery in Patients With Severe Angina
Principal investigator Duncan J. Stewart, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by St. Michael's Hospital, Toronto.