This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial infarction disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
changes of cardiac left ventricular ejection fraction (LVEF, %)
the difference of LVEF before and after treatment between groups.
Time frame: Baseline to 6 months
Quality of Life Measures (SF-36)
Participants will complete SF-36 to measure quality of life at baseline, 3 and 6 months.
Time frame: Baseline to 6 months
Activity Status (DASI)
Participants will complete DASI questionnaires to measure activity status at baseline, 3 and 6 months.
Time frame: Baseline to 6 months
changes of creatinine kinase (CK, U/L) within 24 hours post delivery.
the difference of creatinine kinase (CK, U/L) before and after delivery within 24 hours.
Time frame: Baseline to 24 hours post delivery.
changes of troponin (μg/L) within 24 hours post delivery.
the difference of troponin (μg/L) before and after delivery within 24 hours
Time frame: Baseline to 24 hours post delivery.
number of participants with evidence of any systemic embolization within 1 week post delivery.
number of participants with evidence of any systemic embolization during the hospitalization period post delivery.
Time frame: Baseline to 1 week post delivery.
number of participants with clinically significant changes in ECG than before
number of participants with clinically significant changes in ECG than before
Time frame: Baseline to 6 months
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number of participants with major acute cardiac events (cardiac death and myocardial infarction) during follow-up
number of participants with major acute cardiac events (cardiac death and myocardial infarction) during follow-up
Time frame: Baseline to 6 months
number of participants with revascularization procedures during follow-up
number of participants with revascularization procedures during follow-up
Time frame: Baseline to 6 months