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临床试验/NCT04068116
NCT04068116Unknown不适用

Impact of Ischemic Post-conditioning During Primary Percutaneous Coronary Intervention on Left Ventricular Remodeling and Global Systolic Function in Patients Presenting With ST-Elevation Myocardial Infarction

Assiut University0 个研究点目标入组 100 人开始时间: 2019年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
主要终点
Left ventricular remodeling

研究概览

简要总结

Study will investigate & compare the left ventricular remodeling & systolic function between two groups of ST-elevation myocardial infarction undergoing primary per-cutaneous coronary intervention applying ischemic post-conditioning to one of them.

详细描述

Among re-perfusion strategies for the management of ST-elevation myocardial infarction , primary per-cutaneous coronary intervention is the preferred one within 120 minutes from the first medical contact.However , restoration of the coronary blood flow can paradoxically reduce the beneficial effects of myocardial re-perfusion , a phenomenon known as myocardial re-perfusion injury.Ischemic post-conditioning has been described as a measure for myocardial salvage , performed by making cycles of briefly interrupted perfusion during the early moments of coronary re-flow.Post-conditioning may be performed immediately after the early re-flow by creating cycles of interrupted inflation & deflation of the angioplasty balloon in patients undergoing primary per-cutaneous coronary intervention.In this study investigators aim to compare the left ventricular remodeling and global systolic function immediately & 6 months after re-perfusion between two groups of 100 patients presenting with acute ST-elevation myocardial infarction, using ischemic post-conditioning in one group of patients undergoing primary per-cutaneous coronary intervention (n=50 patients) by making 4 cycles of repeated occlusion & re-perfusion 30-second each by inflation/deflation of an appropriately sized per-cutaneous trans-luminal coronary angioplasty balloon.The other group will be investigated after re-perfusion by primary per-cutaneous coronary intervention without ischemic post-conditioning (n=50 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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients presenting with symptoms of acute myocardial ischemia with time of symptom onset < 12 hours & meeting the other following criteria of type 1 myocardial infarction according to the fouth universal definition of myocardial infarction(Thygesen, 2019):
  • •Detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit.(URL)
  • •Ischemic ECG changes; New or persistent ST-segment elevation with development of pathological Q waves
  • •Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology.
  • •Patients undergoing primary percutaneous coronary intervention as the first choice of revascularization therapy.

排除标准

  • •Patients with transient ST segment elevation in the surface electrocardiography.
  • •Patients presenting within > 12 hours from the onset of maximal symptoms.
  • •Patients with evidence of pre-infarction angina.
  • •Patients with evidence of collateral blood flow to the infarct region on their angiogram.
  • •Patients with history of old myocardial infarction causing chronic impairment of LV systolic function.
  • •Patients presenting with ST-segment elevation myocardial infarction other than type 1 according to the fouth universal definition of myocardial infarction

研究组 & 干预措施

Postconditioning in primary percutaneous coronary intervention

Experimental

Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention with post-conditioning by making 4 cycles of repeated occlusion & re-perfusion 30-second each by inflation/deflation of an appropriately sized PTCA (per-cutaneous trans-luminal coronary angioplasty) balloon

干预措施: Primary per-cutaneous coronary intervention (Procedure)

Primary percutaneous coronary intervention

Active Comparator

Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention without post-conditioning

干预措施: Primary per-cutaneous coronary intervention (Procedure)

结局指标

主要结局

Left ventricular remodeling

时间窗: Immediate-6 months

percentage of increase in left ventricular end-diastolic volume (EDV) and/or left ventricular end-systolic volume (ESV)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Fathi Ahmad

Cardiologist

Assiut University

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