|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00143585 |
|
Date of registration:
|
01/09/2005 |
|
Primary sponsor: |
|
|
Public title:
|
NOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial
|
|
Scientific title:
|
Multicentre, Randomized,Double Blind,Placebo Controlled Trial of Myocardial Angiogenesis Using VEGF165, Intramyocardial Gene Delivery in Patients With Severe Angina |
|
Date of first enrolment:
|
June 2002 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00143585 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Duncan J. Stewart, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
St. Michael's Hospital, Toronto |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Myocardial Ischemia
|
|
Intervention(s)
|
|
Procedure: intramyocardial delivery of either VEGF165 or placebo
|
|
Primary Outcome(s)
|
|
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(s)
|
|
symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|