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

Purpose

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

Condition	Intervention	Phase
Myocardial Ischemia	Procedure: intramyocardial delivery of either VEGF165 or placebo	Phase II Phase III

MedlinePlus related topics:

Angina Exercise and Physical Fitness Nuclear Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

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

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	June 2002
Estimated Study Completion Date:	June 2007

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143585

Locations


Canada, Alberta
	University of Alberta
	Edmonton, Alberta, Canada, T6G 2B7

Canada, British Columbia
	Victoria Heart Institute Foundation
	Victoria, British Columbia, Canada, V8R 6R5

Canada, Ontario
	St. Michael's Hospital
	Toronto, Ontario, Canada, M4P 2K2
	Mount Sinai
	Toronto, Ontario, Canada, M5G 1X5
	Sunnybrook Health Sciences Centre
	Toronto, Ontario, Canada, M4N 3M5

Canada, Quebec
	Montreal Heart Institute
	Montreal, Quebec, Canada, H1T 1C8
	Institute de Cardiologie, Hopital Laval
	Quebec City, Quebec, Canada, G1V4G5

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Investigators


Principal Investigator:	Duncan J. Stewart, MD	St. Michael's Hospital, Toronto

More Information

Study ID Numbers:	02-065
First Received:	September 1, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00143585
Health Authority:	Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:

angiogenesis

VEGF

Study placed in the following topic categories:

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Angina Pectoris

Ischemia

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	St. Michael's Hospital, Toronto
Information provided by:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT00143585