To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00090714
Recruitment Status : Unknown
Verified April 2006 by Corautus Genetics.
Recruitment status was:  Active, not recruiting
First Posted : September 6, 2004
Last Update Posted : April 20, 2006
Information provided by:
Corautus Genetics

Brief Summary:
The purpose of this study is to determine the optimum effective dose of recombinant plasmid DNA [pVGI.1(VEGF2)] gene therapy administered using an experimental cardiac direct injection catheter (Stiletto™) system needed to benefit patients with severe Angina Pectoris.

Condition or disease Intervention/treatment Phase
Angina Pectoris Genetic: pVGI.1(VEGF2) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources

Primary Outcome Measures :
  1. Exercise Tolerance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Are willing and able to give informed consent
  • 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:

  • Have exercise-limited non-cardiac chest discomfort
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00090714

  Hide Study Locations
United States, Alabama
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
Mayo Clinic Hospital/Scottsdale
Phoenix, Arizona, United States, 85054
United States, California
Scripps Green Medical Center
LaJolla, California, United States, 92037
United States, Colorado
Aurora Denver Cardiology Associates
Aurora, Colorado, United States, 80012
United States, District of Columbia
Washington Heart
Washington, District of Columbia, United States, 20010
United States, Florida
Shands Hospital - Jacksonville, FL
Jacksonville, Florida, United States, 32209
United States, Georgia
Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Fuqua Heart Center of Piedmont Hospital
Atlanta, Georgia, United States, 30309
St. Joseph Hospital of Atlanta
Atlanta, Georgia, United States, 30342
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
Midwest Heart Foundation
Lombard, Illinois, United States, 60148
Prairie Cardiovascular
Springfield, Illinois, United States, 62701
United States, Indiana
The Care Group, LLC
Indianapolis, Indiana, United States, 46290
United States, Iowa
Midwest CV Research Foundation
Davenport, Iowa, United States, 52803
United States, Maryland
Medstar Research
Towson, Maryland, United States, 21218
United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135-2997
United States, Michigan
Borgess Research Institute
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Mayo Clinic Hospital/Rochester
Rochester, Minnesota, United States, 55902
United States, Nebraska
Nebraska Heart Institute
Lincoln, Nebraska, United States, 68504
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10021
Columbia Presbyterian
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
United States, Oklahoma
Oklahoma Cardiovascular Research
Oklahoma City, Oklahoma, United States, 73120
United States, Tennessee
Baptist Hospital of East Tennessee
Knoxville, Tennessee, United States, 37920
United States, Texas
Baylor University Hospital
Dallas, Texas, United States, 75226
Texas Heart Institute
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030
Cardiovascular Associates of East Texas
Tyler, Texas, United States, 75701
United States, Vermont
Fletcher Allen Healthcare
Burlington, Vermont, United States, 05401
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
United States, Wisconsin
Heart Care Milwaukee, WI
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Corautus Genetics Identifier: NCT00090714     History of Changes
Other Study ID Numbers: VEGF2-CAD-CL-007
NIH RAC # 0301-567
First Posted: September 6, 2004    Key Record Dates
Last Update Posted: April 20, 2006
Last Verified: April 2006

Keywords provided by Corautus Genetics:
Gene Therapy

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms