The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4 is effective in improving exercise capacity measured by exercise treadmill testing, angina functional class, patient symptoms, quality of life, and cardiovascular outcomes. Two doses will be studied, 2.87 x 10(8) and 2.87 x 10(9) viral particles, to evaluate the dose-response 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
416
Intracoronary infusion
Change in treadmill exercise duration from baseline
Time frame: 12 Weeks
Percentage of patients with a =>30% increase in exercise duration compared to baseline
Time frame: 4 weeks, 12 weeks and 6 months
Number of patients with and time to coronary events or all-cause death
Time frame: 1 Year
Change in treadmill exercise duration compared to baseline
Time frame: 4 weeks and 6 months
Change in time to 1 mm ST segment depression during ETT compared to baseline
Time frame: 4 weeks, 12 weeks and 6 months
Change in time to angina onset during ETT compared to baseline
Time frame: 4 weeks, 12 weeks and 6 months
Change in CCS class compared to baseline
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months and 12 months
Change in weekly frequency of anginal attacks compared to baseline
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months
Change in weekly PRN nitroglycerin use compared to baseline
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months
Change in quality of life (SAQ, DASI, SF-36, EQ-5D) compared to baseline
Time frame: 4 weeks, 12 weeks, 6 months and 12 months
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