To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter
NCT ID: NCT00090714
Last Updated: 2006-04-20
Study Results
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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UNKNOWN
PHASE2
404 participants
INTERVENTIONAL
2004-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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pVGI.1(VEGF2)
Eligibility Criteria
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Inclusion Criteria
* Have CCS class III or IV angina refractory to optimized medical therapy
* Experience signs or symptoms of angina during the exercise tolerance test (ETT)
* Have identified area(s) of reversible ischemic myocardium
* Have procedurally acceptable targeted treatment zones
Exclusion Criteria
* Unwilling or unable to undergo exercise testing
* Able to exercise greater than 6 minutes on the treadmill
* Are candidates for conventional revascularization procedures
* Are or have been enrolled within 30 days, in another experimental study
* Have had the most recent angiogram more than 6 Months prior to screening
* Previously received an investigational angiogenic agent
* Have another disease severe enough to limit exercise test or place patient at risk
* Have uncontrolled: atrial fibrillation, atrial flutter, and/or significant arrhythmias
* Have evidence of left ventricular aneurysm or ventricular thrombus
* Are unwilling or unable to undergo cardiac catheterization or nuclear testing procedures
* Have had a Q-wave MI, within 60 days
* Have severe aortic valve stenosis or have a mechanical aortic or mitral valve
* Have unstable angina or an acute non-Q-wave myocardial infarction within 14 days
* Have had a documented stroke or transient ischemic attack within 60 days
* Are pacemaker dependent
* Have a recent history of active diabetic retinopathy or age-related wet macular degeneration
* Have a history of cancer within the last 5 yrs. or have current evidence of a malignant neoplasm
* Have a history of alcohol or drug abuse within 90 days
* Are pregnant or lactating
* Have reproductive potential and are unwilling to use condoms for contraception for 1 year after treatment - both male and female
* Are unable to return to the clinic for the scheduled follow-up appointments
* Are taking medications which may produce an undue risk
* Have areas of LV wall less than 6mm thick
18 Years
ALL
No
Sponsors
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Corautus Genetics
INDUSTRY
Locations
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Cardiology, P.C.
Birmingham, Alabama, United States
Arizona Heart Institute
Phoenix, Arizona, United States
Mayo Clinic Hospital/Scottsdale
Phoenix, Arizona, United States
Scripps Green Medical Center
La Jolla, California, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, United States
Washington Heart
Washington D.C., District of Columbia, United States
Shands Hospital - Jacksonville, FL
Jacksonville, Florida, United States
Crawford Long Hospital
Atlanta, Georgia, United States
Fuqua Heart Center of Piedmont Hospital
Atlanta, Georgia, United States
St. Joseph Hospital of Atlanta
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Evanston Northwestern Healthcare
Evanston, Illinois, United States
Midwest Heart Foundation
Lombard, Illinois, United States
Prairie Cardiovascular
Springfield, Illinois, United States
The Care Group, LLC
Indianapolis, Indiana, United States
Midwest CV Research Foundation
Davenport, Iowa, United States
Medstar Research
Towson, Maryland, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Borgess Research Institute
Kalamazoo, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Mayo Clinic Hospital/Rochester
Rochester, Minnesota, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
New York Presbyterian Hospital
New York, New York, United States
Columbia Presbyterian
New York, New York, United States
University of Rochester
Rochester, New York, United States
Durham VA Medical Center
Durham, North Carolina, United States
Oklahoma Cardiovascular Research
Oklahoma City, Oklahoma, United States
Baptist Hospital of East Tennessee
Knoxville, Tennessee, United States
Baylor University Hospital
Dallas, Texas, United States
Texas Heart Institute
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Cardiovascular Associates of East Texas
Tyler, Texas, United States
Fletcher Allen Healthcare
Burlington, Vermont, United States
Swedish Medical Center
Seattle, Washington, United States
Heart Care Milwaukee, WI
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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NIH RAC # 0301-567
Identifier Type: -
Identifier Source: secondary_id
VEGF2-CAD-CL-007
Identifier Type: -
Identifier Source: org_study_id