The purpose of this study is to determine whether a one-time intracoronary infusion of Ad5FGF-4 is effective in reducing the time to onset myocardial ischemia as measured by exercise treadmill testing and improving myocardial blood flow as measured by SPECT imaging. Exercise capacity, angina functional class, patient symptoms and quality of life will also be evaluated to characterize the efficacy of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Change in time to onset of ECG changes diagnostic of myocardial ischemia during ETT
Time frame: Month 6
Change in reversible perfusion defect size as measured by adenosine single-photon emission computed tomography with technetium-99m sestamibi (SPECT)(principal secondary endpoint)
Time frame: Month 6
Change in total exercise treadmill time
Time frame: Months 3, 6 and 12
Change in time to onset ECG changes diagnostic myocardial ischemia during ETT
Time frame: Months 3 and 12
Change in time to onset of angina during ETT
Time frame: Months 3, 6 and 12
Change in angina frequency and nitroglycerin
Time frame: Months 3 and 6
Change in patient functional status using CCS angina class
Time frame: Months 3, 6 and 12
Change in rest and stress left ventricular ejection fraction assessed using gated SPECT
Time frame: Month 6
Change in quality of life using the Seattle Angina Questionnaire
Time frame: Months 6 and 12
Safety of Ad5FGF-4 as assessed by adverse events and clinical laboratory testing
Time frame: Through month 12
Long-term safety of Ad5FGF-4 as assessed by clinically important events
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University of Alabama
Birmingham, Alabama, United States
Banner Heart Hospital
Phoenix, Arizona, United States
Southwest Heart
Tucson, Arizona, United States
Access Clinical Trials
Beverly Hills, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Mission Internal Medical Group
Mission Viejo, California, United States
UCSD Medical Center
San Diego, California, United States
Aurora Denver Cardiology
Aurora, Colorado, United States
South Denver Cardiology
Littleton, Colorado, United States
Cardiovascular Research Institute
Washington D.C., District of Columbia, United States
...and 37 more locations
Time frame: Through month 60