Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Final infarct size evaluated by MR
研究概览
简要总结
Standard treatment of patients with acute ST-segment elevation myocardial infarction consist of acute re-opening of the occluded coronary artery (primary PCI). Despite successful treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies have indicated that graded re-opening of the artery may limit tissue damage. Generally this is referred to as mechanical postconditioning.
The study investigates the effect on final infarct size evaluated by magnetic resonance scan of postconditioning of ST-segment elevation myocardial infarctions. Mechanical postconditioning is performed by means of several balloon inflations in the injured vessel following its acute re-opening.
详细描述
Please see above
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 (Participant)
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
- •Patients more than 18 years
- •STEMI < 12 hours
- •TIMI 0-1 in infarct related artery
排除标准
- •Multivessel disease (stenoses in non-infarct related arteries >70%)
- •Cardiogenic shock
- •Left main occlusions
- •Lesions that cannot be treated with stents
- •Previous CABG
- •Pregnancy
- •Severe renal insufficiency
- •Previous extensive Q-wave infarction
研究组 & 干预措施
Mek postcon
Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel.
干预措施: Mechanical postconditioning (Procedure)
Standard treatment
Standard treatment (primary PCI)
干预措施: Standard primary PCI (Procedure)
结局指标
主要结局
Final infarct size evaluated by MR
时间窗: 3 month
次要结局
- Stent thrombosis(15 month)
- MACE (death, re-infarction, TLR)(1, 15 month)
研究者
Thomas Engstrom
Chief Consultant
Rigshospitalet, Denmark