Clinical trial NCT00090714: To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Angina Pectoris
Keywords: DNA
Circular
Gene Therapy
Lead sponsor: Corautus Genetics
Sponsor class: INDUSTRY
First posted: 2004-09-06
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Exercise Tolerance
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology, P.C.
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Hospital/Scottsdale
state: Arizona
city: LaJolla
country: United States
facility: Scripps Green Medical Center
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Washington
country: United States
facility: Washington Heart
state: District of Columbia
city: Jacksonville
country: United States
facility: Shands Hospital - Jacksonville, FL
state: Florida
city: Atlanta
country: United States
facility: Crawford Long Hospital
state: Georgia
city: Atlanta
country: United States
facility: Fuqua Heart Center of Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: St. Joseph Hospital of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Lombard
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Springfield
country: United States
facility: Prairie Cardiovascular
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group, LLC
state: Indiana
city: Davenport
country: United States
facility: Midwest CV Research Foundation
state: Iowa
city: Towson
country: United States
facility: Medstar Research
state: Maryland
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Hospital/Rochester
state: Minnesota
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Columbia Presbyterian
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research
state: Oklahoma
city: Knoxville
country: United States
facility: Baptist Hospital of East Tennessee
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Hospital
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Tyler
country: United States
facility: Cardiovascular Associates of East Texas
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Healthcare
state: Vermont
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Heart Care Milwaukee, WI
state: Wisconsin
Study officials:
References: