Clinical trial NCT00143585: NOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial
Official title: Multicentre, Randomized,Double Blind,Placebo Controlled Trial of Myocardial Angiogenesis Using VEGF165, Intramyocardial Gene Delivery in Patients With Severe Angina
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Myocardial Ischemia
Keywords: angiogenesis
VEGF
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

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
Secondary outcomes:
measure: symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Victoria
country: Canada
facility: Victoria Heart Institute Foundation
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec City
country: Canada
facility: Institute de Cardiologie, Hopital Laval
state: Quebec
Study officials:
affiliation: Unity Health Toronto
name: Duncan J. Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References: