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临床试验/NCT02670005
NCT02670005Unknown不适用

Fractional Flow Reserve Versus Angiography for Guiding Selective Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction

Nanjing Medical University0 个研究点目标入组 600 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
主要终点
Major adverse cardiac events

研究概览

简要总结

To assess the outcomes of patients with ST-segment elevation myocardial infarction (STEMI) assigned to fractional flow reserve (FFR) and angiography-guided selective percutaneous coronary intervention (PCI).

详细描述

The investigators retrospectively collect STEMI patients received selective PCI from Jan 2012 to Dec 2015. Clinical follow-up is performed from the date of FFR assessment to Dec 2016 or death, which is up to 5 years. The primary endpoint is major adverse cardiac events, composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. The primary endpoints are cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. All deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established. Reinfarction is defined as myocardial infarction after the PCI procedure. Unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of angina, ventricular arrhythmias and heart failure. All patients were received FFR-guided PCI or angiography-guided PCI before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age>18 years
  • documented acute ST-segment elevation myocardial infarction
  • onset of symptom >6 days before percutaneous coronary intervention
  • eligible for PCI

排除标准

  • cardiogenic shock or hemodynamic instability
  • highly tortuous or calcified arteries
  • infarct related artery with a diameter < 2.5mm
  • a life expectancy< 2 years
  • intolerance to anti-platelet drugs
  • left main disease (≥ 50% stenosis)
  • contraindication to adenosine
  • hypertrophic cardiomyopathy

结局指标

主要结局

Major adverse cardiac events

时间窗: up to 5 years

composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons

次要结局

  • cardiac death(up to 5 years)
  • unplanned hospitalization due to cardiovascular reasons(up to 5 years)
  • reinfarction(up to 5 years)

研究者

发起方
Nanjing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin Geng

MD

Nanjing Medical University

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