NCT01538771已完成2 期
The Efficacy of IntraCoronary Erythropoietin Delivery BEfore Reperfusion: Gauging Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction (ICEBERG).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Peak CK-MB/ Troponin-I levels
研究概览
简要总结
Prospective, randomized and open label trial
Hypothesis
- Infusion of intracoronary darbepoetin-alpha at the time of reperfusion may reduce infarct size and post-infarct pathologic left ventricular remodeling in patients with ST-segment elevation myocardial infarction.
Methods
- Randomization into control group or treatment group
- Treatment group : Darbepoetin-alpha 300ug intracoronary bolus infusion via over-the-wire balloon system simultaneously with first balloon inflation and conventional treatment
- Control group : conventional treatment
Endpoints
- peak CK-MB & troponin levels : baseline,6h,12hr,18hr, 24hr, 36hr and 48hr
- MRI at baseline : infarct size, area at risk and salvaged myocardium
- MRI at 4 months : prevalence of pathologic left ventricle remodeling (definition: increase of end-diastolic volume index > 20% compared to baseline)
- safety endpoint : cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptom, bleeding and urgent target lesion revascularization
详细描述
[Eligibility Criteria]
- Patients, regardless of gender, at the age from 18 to 80 years were eligible if they had within 12 hours of onset of ST-segment myocardial infarction that was decided to treat with primary percutaneous coronary intervention.
[Exclusion criteria]
- Uncontrolled congestive heart failure (Killip classes II and III, or cardiogenic shock)
- History of malignancy
- Serious hematological disease
- Current infectious disease requiring antibiotic therapy
- Baseline creatinine level > 2.0 mg/dL or dependence on dialysis
- Known hypersensitivity to or contraindication for heparin, aspirin, clopidogrel, sirolimus, everolimus, contrast medium and darbepoetin-α
[Primary endpoint] Myocardial infarct size, estimated by measurement of peak levels of cardiac biomarker (CK-MB and troponin-I of the patients was followed for 48 hours at every 6 hours)
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ST-elevation myocardial infarction (MI) within 12 hours of onset
- •Suitable coronary anatomy for PCI
- •Age < 80 yrs
排除标准
- •Uncontrolled congestive heart failure (Killip classes II and III, or cardiogenic shock)
- •History of malignancy
- •Serious hematological disease
- •Current infectious disease requiring antibiotic therapy
- •Baseline creatinine level > 2.0 mg/dL or dependence on dialysis
- •Known hypersensitivity to or contraindication for heparin, aspirin, clopidogrel, sirolimus, everolimus, contrast medium and darbepoetin-α
研究组 & 干预措施
Control group
Placebo Comparator
Received same volume of saline
干预措施: Control Saline (Drug)
Darbepoetin group
Active Comparator
Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning & conventional treatment
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Peak CK-MB/ Troponin-I levels
时间窗: baseline, 6, 12,18,24,36,48hrs
次要结局
- Change of left ventricular ejection fraction, LV end-diastolic volume , and LV end-systolic volume assessed by cardiac MRI(Between four days and 4 months)
- Infarct size, area at risk and proportion of salvaged myocardium(Participants will be followed for the duration of hospital stay, an expected average of 4 days)
- Pathologic left ventricle remodeling assessed by cardiac MRI(4 months)
- Composites of cardiovascular endpoints(4 Months)
研究者
Dong-Ju Choi
Principal Investigator
Seoul National University Bundang Hospital
研究点 (1)
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