SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI
研究概览
简要总结
Title: SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction (SWISS-AMI).
Study population: Patients with acute myocardial infarction, treated with primary PCI.
Objective: To determine whether intracoronary infusion of BMCs improves recovery of left ventricular function after acute myocardial infarction treated by PCI
Design: Multi-center, randomized, controlled clinical trial with central core lab analysis for MRI.
Therapy: Intracoronary infusion of BMCs in the infarct related artery at 5-7 days or 3-4 weeks after successful primary PCI
Primary Endpoint: Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI.
Secondary Endpoints:
- Change in LVEF at MRI at 12 months
- Change in regional left ventricular wall motion and thickness at 4 and 12 months.
- Change in infarct size at 4 and 12 months as assessed by "delayed enhancement" technique by MRI
- Analysis of the myocardial infarct size and transmurality, time to PCI and coronary flow characteristics after PCI as predictor of LV remodeling and change after cell therapy
- Change in myocardial perfusion at 4 and 12 months
- Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)
- Major adverse cardiac events (MACE: death, myocardial infarction, TVR (ACBP or PCI, stroke, hospitalization for cardiac reasons) at 12 months
Interventions:
- Aspiration of 50 ml bone marrow (<24 hours) prior to administration
- Intracoronary balloon-based infusion of 10 ml BMCs
- Cardiac MRI at baseline (resp. at hospital discharge), at 4 and 12 months
Therapy groups: Bone marrow-derived stem cells infusion in the successfully revascularized infarct related vessel at day 5-7 or day 21-28.
Control group: Management according to the "state of the art" medical therapy after successful primary PCI.
Safety: A study independent "safety committee" will analyze the clinical results after the first 60 patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visual LVEF at angiogram or echocardiography ≤45%
- •Treatment by primary PCI within 24 hours of the onset of chest pain or initial treatment with thrombolysis within the 12 hours followed by PCI within the 24 hours of the onset of chest pain
- •Significant regional LV wall motion dysfunction in the infarct related territory
- •Age >18 years
排除标准
- •Abnormal regional wall motion outside the infarct region
- •Known previous myocardial infarction in the same target vessel
- •Known pre-existing left ventricular dysfunction (EF<45% prior to admission)
- •Need for revascularization in the non infarct-related coronary within 4 months
- •Pre-existing symptoms of heart failure or known cardiomyopathy
- •Known active infection or chronic infection with HIV, HBV or HCV
- •Chronic inflammatory disease
- •Serious concomitant disease with a life expectancy of less than one year
- •Follow up impossible (no fixed abode, etc)
- •Contraindication for cardiac MRI (i.e. pace maker, neurostimulator, claustrophobia)
- •Severe renal failure (creatinine >250 mmol/l)
- •Relevant liver disease (GOT > 2x norm or spontaneous INR > 1,5)
- •Anemia (Hb < 8.5 mg/dl), Thrombocytopenia (<100.000/µl)
- •Pregnancy
- •Participation at a clinical trial in the last 30 days
结局指标
主要结局
Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI
时间窗: 4 months
次要结局
- Change in LVEF at MRI at 12 months(12 months)
- Change in regional left ventricular wall motion and thickness at 4 and 12 months(4 and 12 months)
- Change in infarct size at 4 and 12 months as assessed by "delayed enhancement" technique by MRI(4 and 12 months)
- Analysis of the myocardial infarct size and transmurality transmurality, time to PCI and coronary flow characteristics after PCI as predictor of LV remodeling and change after cell therapy(baseline 4 and 12 months)
- Change in myocardial perfusion at 4 and 12 months(4 and 12 months)
- Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)(4 and 12 months)
- Major adverse cardiac events (MACE: death, myocardial infarction, TVR (ACBP or PCI, stroke, hospitalization for cardiac reasons) at 12 months(4 and 12 months)