The Effect of Remote Preconditioning in Primary Percutaneous Intervention of Acute ST Elevation Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Salvage index (% of left ventricle): Salvage / Area at Risk (AAR) by SPECT
研究概览
简要总结
Primary percutaneous coronary intervention (pPCI) is the preferred treatment in ST elevation myocardial infarction (STEMI). The infarct-related artery (IRA) can be opened in more than 90% of the patients. However, STEMI patients still end up with a persistent perfusion defect of highly variable magnitude indicating that adjunctive treatment may add further protection against tissue damage. Ischemic preconditioning (IPC) is an intervention by which myocardium threatened by ischemia is exposed to short and repeated sublethal ischemic episodes prior to sustained ischemia (local IPC). A systemic response with protection of more remote organs (remote IPC (rIPC)) also can be induced. We have recently found that the infarct reducing effect can be obtained by obstruction of an extremity even though the remote stimulus is initiated during sustained occlusion of a coronary artery, the so-called remote preconditioning (rPerC). The clinical perspective is now to examine if rPerC can reduce the infarct size in patients with unpredictable ischemia in ST elevation myocardial infarction (STEMI). We perform a randomized study where patients en route for pPCI are allocated to either rPerC or a standard treatment to evaluate whether the tissue damage can be reduced. Effect measure will be infarct size determined by scintigraphy (final infarct size and salvage).
详细描述
Primary percutaneous coronary intervention (pPCI) is the preferred treatment in ST elevation myocardial infarction (STEMI). The infarct-related artery (IRA) can be opened in more than 90% of the patients. However, STEMI patients still end up with a persistent perfusion defect of highly variable magnitude indicating that adjunctive treatment may add further protection against tissue damage. Ischemic preconditioning (IPC) is an intervention by which myocardium threatened by ischemia is exposed to short and repeated sublethal ischemic episodes prior to sustained ischemia (local IPC). A systemic response with protection of more remote organs (remote IPC (rIPC)) also can be induced. We have recently found that the infarct reducing effect can be obtained by obstruction of an extremity even though the remote stimulus is initiated after sustained occlusion of a coronary artery, the so-called remote preconditioning (rPerC). The clinical perspective is now to examine if rPerC can reduce the infarct size in patients with unpredictable ischemia in ST elevation myocardial infarction (STEMI). We perform a randomized study where patients en route for pPCI are allocated to either rPerC or a standard treatment to evaluate whether the tissue damage can be reduced. Effect measure will be infarct size determined by scintigraphy (final infarct size and salvage).
Purpose
The purpose of the present study is to examine the utility of rPerC in STEMI patients treated with pPCI. The effect will be evaluated by 1) limitation of infarct size (salvage and final infarct size) determined by myocardial scintigraphy (SPECT), 2) electrocardiographic and angiographic signs of tissue perfusion, 3) release of ischemic markers 5) echocardiographic markers of left ventricular function and 5) clinical end-points (Major Adverse Cardiac Events (MACE: death, reinfarction, need for revascularisation, invalidating stroke)) at discharge and after 30 days.
Description and evaluation of the ethical aspects of the study
Study patients treated with pPCI are randomized to pretreatment with rPerC or no pretreatment (control group). The randomization will take place in the ambulance or at the local hospital. With the aim of not causing unnecessary delays, the pretreatment is discontinued if the patient arrives at the cath. lab. before the pretreatment is completed.The discomfort in connection with the pretreatment has been shown to be minimal.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute chest pain or equivalent symptoms during > 30 minutes.
- •Duration of symptoms < 12 hours.
- •Cumulated ST elevation > 2 mm in two contiguous leads.
- •Age ≥ 18 years.
- •Informed consent
排除标准
- •Previous by-pass surgery.
- •Pulseless femoral artery.
- •Left bundle branch block in ECG (LBBB).
- •Acute MI and/or treatment with thrombolysis within 30 days.
- •Patients treated with cooling or patients who have had cardiac arrest.
- •Diabetic patients
- •Patients with arteriovenous shunts for the purpose of hemodialysis
结局指标
主要结局
Salvage index (% of left ventricle): Salvage / Area at Risk (AAR) by SPECT
时间窗: 30 days
次要结局
- Prompt angiographic success:(Immediate)
- Corrected TIMI frame count (cTFC).(Minutes)
- Final infarct size.(30 days)
- Proportion of patients achieving ≥70% ST-resolution 90 minutes following pPCI(90 minutes)
- Proportion of patients achieving spontaneous ST-resolution before pPCI(Immediate)
- Proportion of patients with increase in ST-elevation during pPCI.(Immediate)
- Time from first ECG to ≥70% ST-resolution (continuous parameter)(Minutes)
- Time from first wire to ≥70% ST-resolution (continuous parameter)(Minutes)
- ST resolution immediately after ending the procedure (evaluated in relation to ST elevation on ECG obtained just prior to the pPCI procedure).(Minutes)
- TIMI flow measured immediately after ending the interventional procedure.(Minutes)
- Myocardial blush.(Minutes)
- Procedure duration.(Minutes)
- Total duration of hospitalisation.(Days)
- MACE after 30 days.(30 days)
- TnT release - determined 90-102 hours after symptom onset.(90-102 hours)
- Echocardiographic data (acute and after 1 month):(30 days)
- WMI.(30 days)
- Left ventricular ejection fraction (LVEF) (%): (EDV - ESV)/EDV.(30 days)
- Myocardial scintigraphy data:(30 days)
- Regional wall motion and regional thickening.(30 days)
- Technical success.(Immediate)