NCT02844283Unknown1 期
Adenovirus Carrying Hepatocyte Growth Factor (Ad-HGF) Treatment for Myocardial Infarction
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 主要终点
- changes of cardiac left ventricular ejection fraction (LVEF, %)
研究概览
简要总结
This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial infarction disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
treatment group
Experimental
Single dose of Ad-HGF given by investigator via intracoronary injection into infarct-related artery
干预措施: Ad-HGF (Drug)
control group
Sham Comparator
0.9% sodium chloride (NaCl) injection of same volume given by investigator via intracoronary injection into infarct-related artery
干预措施: 0.9% NaCl (Other)
结局指标
主要结局
changes of cardiac left ventricular ejection fraction (LVEF, %)
时间窗: Baseline to 6 months
the difference of LVEF before and after treatment between groups.
次要结局
- number of participants with revascularization procedures during follow-up(Baseline to 6 months)
- number of participants with evidence of any systemic embolization within 1 week post delivery.(Baseline to 1 week post delivery.)
- Activity Status (DASI)(Baseline to 6 months)
- changes of creatinine kinase (CK, U/L) within 24 hours post delivery.(Baseline to 24 hours post delivery.)
- changes of troponin (μg/L) within 24 hours post delivery.(Baseline to 24 hours post delivery.)
- Quality of Life Measures (SF-36)(Baseline to 6 months)
- 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(Baseline to 6 months)
研究者
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