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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.
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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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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