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

Myocardial Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00143585
• Other study ID #: 02-065
• Status: Unknown status
• Phase: Phase 2/Phase 3
• First received: September 1, 2005
• Last updated: July 24, 2008
• Start date: June 2002
• Est. completion date: June 2007

Study information

• Verified date: July 2008
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 120
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Procedure:
• intramyocardial delivery of either VEGF165 or placebo

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Institute de Cardiologie, Hopital Laval	Quebec City	Quebec
Canada	Mount Sinai	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Victoria Heart Institute Foundation	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events