NCT00192868Unknown不适用
Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- ST segment resolution
研究概览
简要总结
The purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated acutely with percutaneous coronary intervention.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute onset typical chest pain of < 12 hours' duration
- •ST-elevation of > 4 mm (1mm = 0.1 mV) in contiguous leads of the electrocardiogram
- •High grade stenosis or occlusion of a native major coronary artery that can be crossed with a soft or intermediate tip guidewire
- •Possibility to perform distal protection of the infarct-related artery
排除标准
- •History of previous myocardial infarction
- •Use of fibrinolytic agents for the index infarction
- •Left main stenosis
- •Heavily calcification of abdominal aorta or occlusive iliofemoral disease hampering access to the coronary ostias by the femoral route
- •Known renal failure
- •Other significant cardiac disease
- •Other severe disease with an expected survival < 1 year
- •Known allergy against clopidogrel or contrast media that can not be avoided/limited by medication
- •Linguistic difficulties needing an interpreter
- •Gastrointestinal bleeding within 1 month
- •Childbearing potential or pregnancy
- •Participation in another study
结局指标
主要结局
ST segment resolution
时间窗: 90 min
Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up).
时间窗: immediately after and at 8 month follow up
次要结局
- wall motion index(During hospitalisation: day 3-5)
- Minimal lumen diameter(8 months)
- frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment.(8 months)
- Occurrence of stent thrombosis and MACE.(12 months)
- Restenosis(8 months)
- maximal elevations in blood concentrations of CK-MB enzyme and troponin-T(Post procedure)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Drug Eluting Balloon in peripherAl inTErvention SFAPeripheral Arterial DiseaseNCT01556542Leonardo Bolognese, MD104
暂停
不适用
Drug Eluting Balloon in Peripheral Intervention for In-Stent RestenosisPeripheral Arterial DiseaseNCT01558531Leonardo Bolognese, MD44
Unknown
不适用
Retrospective Study of the Impact of Drug Eluting StentsCoronary Artery DiseaseNCT00487604Providence Health & Services9,800
招募中
不适用
Tracheotomy With and Without Dual Antiplatelet TherapyTracheostomy HemorrhageNCT05058469Asklepios Neurological Clinic Bad Salzhausen300
已完成
不适用
Investigation of Myocardial Protection Efficacy of Cardioplegia Solutions Used in Open Heart SurgeryCardiovascular DiseasesMyocardial Reperfusion InjuryNCT06373549Tamer cebe2