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This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial infarction disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Single dose of Ad-HGF given by investigator via intracoronary injection into infarct-related artery |
|
| control group | Sham Comparator | 0.9% sodium chloride (NaCl) injection of same volume given by investigator via intracoronary injection into infarct-related artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad-HGF | Drug |
| ||
| 0.9% NaCl |
| Measure | Description | Time Frame |
|---|---|---|
| changes of cardiac left ventricular ejection fraction (LVEF, %) | the difference of LVEF before and after treatment between groups. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Measures (SF-36) | Participants will complete SF-36 to measure quality of life at baseline, 3 and 6 months. | Baseline to 6 months |
| Activity Status (DASI) | Participants will complete DASI questionnaires to measure activity status at baseline, 3 and 6 months. |
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Inclusion Criteria:
Male or female 18-80 years of age
Exclusion Criteria:
Significant unprotected left main disease (stenosis of 50% or greater)on diagnostic angiography
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| 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. | 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 | 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. | 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 | Baseline to 6 months |
| 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 | Baseline to 6 months |
| number of participants with revascularization procedures during follow-up | number of participants with revascularization procedures during follow-up | Baseline to 6 months |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |