The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4, delivered during induced transient ischemia, is effective in improving myocardial perfusion, angina functional class, patient symptoms, and quality of life. Short-term (8 weeks) and long-term (12 month) safety of Ad5FGF-4 will also be evaluated. The primary endpoint is change in adenosine triphosphate (ATP) stress SPECT reperfusion defect size.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
One-time intracoronary infusion of Ad5FGF-4 (6x10e9 viral particles in buffer)
Municipal Hospital #15
Moscow, Russia
Change in reversible perfusion defect size (RPDS) as measured by adenosine triphosphate (ATP) single-photon emission computed tomography with technetium-99m sestamibi (SPECT)
Time frame: Baseline and Week 8
Change in angina frequency and nitroglycerin use
Time frame: Baseline and Week 8
Change in quality of life using the Seattle Angina Questionnaire
Time frame: Baseline and Week 8
Change in patient functional class using CCS anginal classification
Time frame: Baseline and Week 8
Safety of Ad5FGF-4 as assessed by adverse events and clinical laboratory testing
Time frame: Through Week 8
Long-term safety of Ad5FGF-4 as assessed by serious adverse events
Time frame: Through Month 12
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