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临床试验/NCT07272408
NCT07272408已完成不适用

Impact of Remote Ischemic Conditioning in Patients Undergoing Primary Percutaneous Coronary Intervention

Helwan University2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2022年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
2
主要终点
Cardiac death

研究概览

简要总结

This study aimed to detect the effects of remote ischemic conditioning on infarct size, global contractility, morbidity, mortality, and renal function in patients undergoing primary percutaneous coronary intervention.

详细描述

Myocardial infarction (MI) generally refers to segmental (regional) myocardial necrosis, typically endocardial in location, secondary to occlusion of an epicardial artery.

Primary percutaneous coronary intervention (PPCI) is a reperfusion therapy that is carried out in patients who usually have ST-segment elevation MI (STEMI) within a specific time window.

During ischemia, metabolic acidosis occurs due to anaerobic metabolism, and ischemic injury ensues. After restoration of blood supply, reactive oxygen species (ROS) production and local inflammation increase secondary injury.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age more than 18 and less than 75 years old.
  • Both sexes.
  • Patients with new ST-segment elevation at the J-point in V1:V6 leads with the cut-point: ≥ 1mm other than leads V2-V3 where the following cut-points apply: ≥ 2mm in men ≥ 40 years; ≥ 2.5mm in men < 40 years, or ≥ 1.5mm in women regardless of age.
  • Patients with new left bundle branch block (LBBB).

排除标准

  • ST-segment elevation myocardial infarction (STEMI) with cardiogenic shock.
  • Severe comorbidities (uncontrolled hypertension, morbid obesity, recent cerebrovascular stroke, respiratory failure, sepsis, and stage 4 & 5 malignancy).
  • End-stage renal disease on hemodialysis.
  • Previous coronary artery bypass graft surgery (CABG).
  • Myocardial infarct within the previous 30 days.
  • Multi-vessel coronary artery disease.
  • Failure of culprit vessel recanalization.
  • Conditions precluding use of remote conditioning ie: paresis of upper limb.
  • Life expectancy of less than 1 year due to a non-cardiac pathology.
  • Patients who receive nephrotoxic drugs such as non-steroidal anti-inflammatory drugs and aminoglycosides.

结局指标

主要结局

Cardiac death

时间窗: 1 month post-procedure

Incidence of cardiac death was recorded.

次要结局

  • Hospitalization for heart failure(1 month post-procedure)
  • Contrast induced nephropathy(1 month post-procedure)
  • Incidence of adverse events(1 month post-procedure)
  • Renal impairment(1 month post-procedure)

研究者

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

Ahmed Yousry Mousa

Resident of Cardiology, Helwan University, Helwan, Egypt

Helwan University

研究点 (2)

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