Efficacy and Safety of Intracoronary Ad5FGF-4 in Patients With Stable Angina (AGENT-3)
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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.
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Ages Eligible for Study:
30 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Aged 30-75 years, male or female, with coronary artery disease
Patients over 50 years of age agree to undergo sigmoidoscopy, unless they have undergone such an exam or colonoscopy within the preceding 36 months with negative findings
CCS angina Class 2 to 4
Stable angina for =>4 weeks despite antianginal drug treatment, and who are able to exercise for at least 3 minutes but no more than 10 minutes on the first qualifying baseline ETT and no more than 12 minutes on the last qualifying baseline ETT using the modified Balke exercise protocol
LVEF =>30% by echocardiography, LV angiogram, or a MUGA scan undertaken within the preceding 12 months
Classic angina or angina equivalent associated with =>1mm ST segment depression (horizontal or down sloping) at least in the first qualifying ETT. The variability in exercise duration (time to grade 3/4 angina or angina equivalent) does not vary by > 20% in 2 consecutive tests
Single, double, or triple vessel coronary artery disease. Patients with 3 vessel disease should have at least 1 proximal major vessel or graft with <70% stenosis
Patients who do not require immediate PTCA or CABG surgery
Provided written informed consent
CCS Class 1 angina
Patients in whom ECG evidence of exercise induced myocardial ischemia is difficult to detect
Intercurrent illness which may interfere with the ability to perform the ETT