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临床试验/KCT0006406
KCT0006406招募中未知

OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON for Non-Infarct Related Artery in Non-ST-Segment Elevation Myocardial Infarction with Multivessel Disease (OPTION-NSTEMI)

Chonnam National University Hospital0 个研究点目标入组 676 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中
入组人数
676

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
19(Year) 至 o Limit(—)
性别
All

入选标准

  • 1) Age = 19 years old
  • 2) Non-ST-segment elevation myocardial infarction
  • ** Angina pectoris or equivalent ischemic chest discomfort with at least 1 of 3 features and,
  • # occurs at rest, usually lasting > 10 minutes
  • # severe and new onset (within the prior 4-6 weeks)
  • # crescendo pattern
  • ** Elevated cardiac biomarkers and,
  • # = 99% value of high-sensitivity cardiac troponin
  • ** No ST-segment elevation = 0.1 mV in = 2 contiguous leads or newly developed left bundle branch block on 12-lead electrocardiogram
  • 3) PCI within 72 hours after symptom development
  • 4) Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
  • 5) Patient's or protector's agreement about study design and the risk of PCI

排除标准

  • 1) Cardiogenic shock at initial presentation or after treatment of infarct-related artery(IRA)*
  • 2) Thrombolysis in Myocardial Infarction(TIMI) flow at non-IRA = 2 at initial coronary angiography
  • 3) Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
  • 4) Non-IRA lesion not suitable for percutaneous coronary intervention(PCI) treatment by operators' decision
  • 5) Chronic total occlusion at non-IRA
  • 6) History of anaphylaxis to contrast agent
  • 7) Pregnancy and lactation
  • 8) Life expectancy < 1-year due to non-cardiac disease
  • 9) Severe valvular disease
  • 10) History of coronary artery bypass graft(CABG), or planned CABG
  • 11) Severe asthma
  • 12) Patient's refusal for study participation
  • * The definition of cardiogenic shock
  • 1) Systolic blood pressure(SBP) < 90mmHg for more than 30min, or needs for vasopressor to maintain equal or more than SBP 90mmHg
  • 2) Pulmonary congestion, or increased left ventricular filling pressure by cardiac catheterization
  • 3) At least one sign of impaired organ perfusion: mental obtundation, pallor, coldness, oliguria, increased blood lactate

研究者

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