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

NCT ID: NCT00143585

Last Updated: 2008-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2007-06-30

Brief Summary

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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

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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.

Conditions

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Myocardial Ischemia

Keywords

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angiogenesis VEGF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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intramyocardial delivery of either VEGF165 or placebo

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Principal Investigators

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Duncan J. Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Victoria Heart Institute Foundation

Victoria, British Columbia, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Mount Sinai

Toronto, Ontario, Canada

Site Status

Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

Institute de Cardiologie, Hopital Laval

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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02-065

Identifier Type: -

Identifier Source: org_study_id