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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00143585

Enrollment

120

Registered

2005-09-02

Start date

2002-06-30

Completion date

2007-06-30

Last updated

2008-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

Keywords

angiogenesis, VEGF

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.

Interventions

PROCEDUREintramyocardial delivery of either VEGF165 or placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026