Myocardial Infarction
Conditions
Keywords
HGF,myocardial infarction
Brief summary
This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial infarction disease.
Interventions
DRUGAd-HGF
OTHER0.9% NaCl
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female 18-80 years of age * Clinical diagnosis of anterior ST-segment elevation myocardial infarction (STEMI) within the last 30 days, with any one of the following 12-lead electrocardiographic changes: * a) Greater than or equal to 2 mm ST-segment elevation) in 2 adjacent electrocardiographic precordial leads * b) A new left bundle branch block AND and an increase in cardiospecific enzymes \>3x CK, or increase in troponin compared to institution laboratory normal ranges * Successful PCI with stent implantation to infarct-related artery within the last 30 days; defined as residual stenosis no greater than 30%, Thrombolysis In Myocardial Infarction (TIMI) flow of at least 2 and a reference diameter of at least \> 2mm * Is considered hemodynamically stable at time of enrollment and immediately prior to Ad-HGF delivery * Screening LVEF for the first 12 enrolled participants, must be no greater than 40% by echocardiography (determined by Simpson's method) performed at least 2 days after revascularization procedure. Subsequent participants enrolled in the trial, must have an LVEF no greater than 45%. (All screening echos done within the first 4 days post percutaneous coronary intervention (PCI) must be repeated either by echocardiography or MRI prior to Ad-HGF delivery to ensure that the variability does not exceed 10%) * In the case of a previous myocardial infarction, documented LVEF must be 50% or greater * Female participants must be surgically sterile, post-menopausal, have documented infertility, or are of child-bearing potential wih laboratory confirmation of non-pregnant state * Provided written informed consent and is willing to comply with study follow-up visits
Exclusion criteria
* Significant unprotected left main disease (stenosis of 50% or greater)on diagnostic angiography * An increase in LVEF by greater that 10% from initial LVEF evaluation for repeat assessments * The presence of significant coronary lesions, other than the index lesion of the infarction related artery * A history of significant ventricular arrhythmia not related to index STEMI * A history of cerebro-vascular accident or transient ischemic attack within 6 months of enrollment * Inability to undergo apheresis procedure(i.e.: poor venous access, laboratory abnormalities * A history of uncorrected significant valvular heart disease * A history of left ventricular dysfunction prior to index STEMI * A history of human immunodeficiency virus (HIV)or hepatitis B or C infection * A history of malignancy within 5 years (Except for low-grade and fully resolved non-melanoma skin cancer) * A history of allergy to gentamycin or amphotericin * A history of non-compliance * Active inflammatory autoimmune disease requiring chronic immunosuppressive therapy * Creatinine clearance \<60 by Cockcroft-Gault Calculator * Confirmed pregnant or lactating * Is enrolled in a current investigational drug or device trial * Participant has received cell or gene therapy in past * The presence of any significant co-morbidities that, in the investigator's opinion, would preclude the participant from taking part in the trial * Inability to provide informed consent and comply with the follow-up visit schedule
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes of cardiac left ventricular ejection fraction (LVEF, %) | Baseline to 6 months | the difference of LVEF before and after treatment between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity Status (DASI) | Baseline to 6 months | Participants will complete DASI questionnaires to measure activity status at baseline, 3 and 6 months. |
| changes of creatinine kinase (CK, U/L) within 24 hours post delivery. | Baseline to 24 hours post delivery. | the difference of creatinine kinase (CK, U/L) before and after delivery within 24 hours. |
| changes of troponin (μg/L) within 24 hours post delivery. | Baseline to 24 hours post delivery. | the difference of troponin (μg/L) before and after delivery within 24 hours |
| Quality of Life Measures (SF-36) | Baseline to 6 months | Participants will complete SF-36 to measure quality of life at baseline, 3 and 6 months. |
| number of participants with clinically significant changes in ECG than before | Baseline to 6 months | number of participants with clinically significant changes in ECG than before |
| number of participants with major acute cardiac events (cardiac death and myocardial infarction) during follow-up | Baseline to 6 months | number of participants with major acute cardiac events (cardiac death and myocardial infarction) during follow-up |
| number of participants with revascularization procedures during follow-up | Baseline to 6 months | number of participants with revascularization procedures during follow-up |
| number of participants with evidence of any systemic embolization within 1 week post delivery. | Baseline to 1 week post delivery. | number of participants with evidence of any systemic embolization during the hospitalization period post delivery. |
Outcome results
None listed