Ad-HGF Treatment for Myocardial Infarction
- Registration Number
- NCT02844283
- Brief Summary
This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial infarction disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group 0.9% NaCl 0.9% sodium chloride (NaCl) injection of same volume given by investigator via intracoronary injection into infarct-related artery treatment group Ad-HGF Single dose of Ad-HGF given by investigator via intracoronary injection into infarct-related artery
- Primary Outcome Measures
Name Time Method changes of cardiac left ventricular ejection fraction (LVEF, %) Baseline to 6 months the difference of LVEF before and after treatment between groups.
- Secondary Outcome Measures
Name Time Method 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.
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