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

April 18, 2006 updated by: Corautus Genetics
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

404

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Cardiology, P.C.
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Arizona Heart Institute
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital/Scottsdale
    • California
      • LaJolla, California, United States, 92037
        • Scripps Green Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Aurora Denver Cardiology Associates
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Heart
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Shands Hospital - Jacksonville, FL
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Crawford Long Hospital
      • Atlanta, Georgia, United States, 30309
        • Fuqua Heart Center of Piedmont Hospital
      • Atlanta, Georgia, United States, 30342
        • St. Joseph Hospital of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare
      • Lombard, Illinois, United States, 60148
        • Midwest Heart Foundation
      • Springfield, Illinois, United States, 62701
        • Prairie Cardiovascular
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • The Care Group, Llc
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Midwest CV Research Foundation
    • Maryland
      • Towson, Maryland, United States, 21218
        • Medstar Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02135-2997
        • Caritas St. Elizabeth's Medical Center
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Research Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Hospital/Rochester
    • Nebraska
      • Lincoln, Nebraska, United States, 68504
        • Nebraska Heart Institute
    • New York
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital
      • New York, New York, United States, 10032
        • Columbia Presbyterian
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Cardiovascular Research
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Baptist Hospital of East Tennessee
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor University Hospital
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Houston, Texas, United States, 77030
        • Texas Heart Institute
      • Tyler, Texas, United States, 75701
        • Cardiovascular Associates of East Texas
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Healthcare
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Heart Care Milwaukee, WI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Exercise Tolerance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corautus Genetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Registration Dates

First Submitted

September 2, 2004

First Submitted That Met QC Criteria

September 3, 2004

First Posted (Estimate)

September 6, 2004

Study Record Updates

Last Update Posted (Estimate)

April 20, 2006

Last Update Submitted That Met QC Criteria

April 18, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEGF2-CAD-CL-007
  • NIH RAC # 0301-567

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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