Clinical Trial: To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients when given with an Experimental Injection Catheter

This study is currently recruiting patients.

Sponsored by: Corautus Genetics
Information provided by: Corautus Genetics

Purpose

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 Treatment or Intervention Phase
Angina Pectoris
 Gene Transfer: pVGI.1(VEGF2)
Phase II

MedlinePlus related topics:  Angina

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

Further Study Details: 

Expected Total Enrollment:  404

Study start: August 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Location and Contact Information


Alabama
      Cardiology, P.C., Birmingham,  Alabama,  35211,  United States; Recruiting
Susan DeRamus  205-780-4330  Ext. 338    sderamus@cardiologypc.com 
Farrell Mendelsohn, MD,  Principal Investigator

Arizona
      Mayo Clinic, Phoenix,  Arizona,  85054,  United States; Recruiting
Debbie Unger  480-342-1193    unger.deborah@mayo.edu 
David Fortuin, MD,  Principal Investigator

      Arizona Heart Institute, Phoenix,  Arizona,  85006,  United States; Recruiting
Kellye Wagner  602-266-2200    KWagner@azheart.com 
Nabil Dib, MD,  Principal Investigator

California
      Scripps Clinic, LaJolla,  California,  92037,  United States; Recruiting
Richard Schatz, MD  858-554-5153 
Richard Schatz, MD,  Principal Investigator

District of Columbia
      Washington Heart, Washington,  District of Columbia,  20010,  United States; Recruiting
Petros Okubagz  202-877-2146    petros.g.okubagzi@medstar.net 
Ronald Waksman, MD,  Principal Investigator

Georgia
      Crawford Long Hospital, Atlanta,  Georgia,  30308,  United States; Not yet recruiting
Jayne Danley  404-686-7468    jayne_danley@emoryhealthcare.org 
Henry Liberman, MD,  Principal Investigator

      Fuqua Heart Center of Piedmont Hospital, Atlanta,  Georgia,  30309,  United States; Recruiting
Kristi Picardi  404-605-2409    kristi.picardi@piedmont.org 
Charles Brown, MD,  Principal Investigator

Illinois
      Rush University, Chicago,  Illinois,  60612,  United States; Recruiting
Stephanie Guzik  312-942-3391    stephanie_marshall@rush.edu 
Gary Schaer, MD,  Principal Investigator

      Midwest Heart Foundation, Lombard,  Illinois,  60148,  United States; Recruiting
Kathleen Franke  630-932-2165    kfranke@midwestheart.org 
Louis McKeever, MD,  Principal Investigator

      Evanston Northwestern Healthcare, Evanston,  Illinois,  60201,  United States; Recruiting
Beth Garnier, RN  847-570-1997    egarnier@enh.org 
Timothy Sanborn, MD,  Principal Investigator

Massachusetts
      Caritas St. Elizabeth's Medical Center, Boston,  Massachusetts,  02135-2997,  United States; Recruiting
Ann Pieczek  617-789-3043    annpieczek@lycos.com 
Douglas Losordo, MD,  Principal Investigator

Minnesota
      Minneapolis Heart Institute, Minneapolis,  Minnesota,  55407,  United States; Recruiting
Karen Harvey  612-863-1661    kharvey@mplsheart.com 
Tim Henry, MD,  Principal Investigator

      Mayo Clinic, Rochester,  Minnesota,  55902,  United States; Recruiting
Cindy Woltman  507-266-4095    woltman.cindy@mayo.edu 
Robert Simari, MD,  Principal Investigator

New York
      Columbia Presbyterian, New York,  New York,  10032,  United States; Recruiting
Jamie Salsberg  212-342-3475    jas2020@columbia.edu 
Margaret Jones  212-342-3475    mj2019@columbia.edu 
Jeffrey Moses, MD,  Principal Investigator

      Cornell - Weil Medical College, New York,  New York,  10021,  United States; Not yet recruiting
Lynn Santiago  212-746-4617    lms2006@med.cornell.edu 
Shing-Chiu Wong, MD,  Principal Investigator

North Carolina
      Durham VA Medical Center, Durham,  North Carolina,  27705,  United States; Recruiting
Marilyn Powell  919-286-0411    marilyn.powell@med.va.gov 
Brian Annex, MD,  Principal Investigator

Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Not yet recruiting
Stephen Ellis, MD
Stephen Ellis, MD,  Principal Investigator

Tennessee
      Baptist Hospital of East Tennessee, Knoxville,  Tennessee,  37920,  United States; Recruiting
Beth Polk  865-549-4605    bpolk@bhset.org 
Malcolm Foster, MD,  Principal Investigator

Texas
      Texas Heart Institute, Houston,  Texas,  77030,  United States; Recruiting
Mary Harlan  832-355-3710    mharlan@heart.thi.tmc.edu 
Emerson Perin, MD,  Principal Investigator

Washington
      Swedish Medical Center, Seattle,  Washington,  98104,  United States; Recruiting
Inger Rasmussen  206-215-2437    inger.rasmussen@swedish.org 
Mark Reisman, MD,  Principal Investigator

More Information

Study ID Numbers:  VEGF2-CAD-CL-007; NIH RAC # 0301-567
Record last reviewed:  March 2005
Last Updated:  March 23, 2005
Record first received:  September 2, 2004
ClinicalTrials.gov Identifier:  NCT00090714
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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