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临床试验/NCT04068779
NCT04068779已完成不适用

Long-term Clinical Outcomes in Patients With FFR GuidEd-DeFERred CoRonAry Lesions, Assessed by IVUS Analysis

Keimyung University Dongsan Medical Center1 个研究点 分布在 1 个国家目标入组 459 人开始时间: 2019年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
459
试验地点
1
主要终点
patient-oriented composite outcome

研究概览

简要总结

This study was a multicenter retrospective study that included intravascular ultrasound (IVUS) in patients with delayed stent insertion based on fractional flow reserve (FFR) in moderately narrowed coronary lesions. We would like to see the effect of lesion characteristics on clinical course.

详细描述

From January 2007 to August 2014, patients who meet the criteria for selection and exclusion from Keimyung University Dongsan Hospital, Seoul National University Hospital, Inje University Busan Paik Hospital, and Ulsan University Hospital are included.

  1. Target patient screening The database will select patients who meet the selection and exclusion criteria.
  2. target patient characteristics The age, sex, smoking status, medical history (hypertension, diabetes mellitus, hyperlipidemia), diagnosis, and left ventricular blood count measured by echocardiography should be checked through a computerized medical record.
  3. coronary angiography Coronary angiography images of the subjects in the blinded state are analyzed to investigate the length of lesions, reference vessel diameter, and minimal vessel diameter.
  4. intravascular ultrasound In the blinded state, the vessel's vessel area, plaque area, lumen area, etc. are measured by analyzing intravascular ultrasound images of the patient using EchoPlaque (Indec Systems, Mountain View, CA).

研究设计

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

入排标准

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

入选标准

  • Subject over 19 years old
  • Patients with mild or moderate stenosis lesions on coronary angiography
  • Patients with lesions with FFR values greater than 0.80
  • Patients with analytical intravascular ultrasound images

排除标准

  • Left main lesion
  • History of coronary artery bypass grafting
  • Patients with lower left ventricular ejection fraction (<25%)

结局指标

主要结局

patient-oriented composite outcome

时间窗: during 5-year

all-cause death, myocardial infarction and any revascularization

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

Yun-kyeong Cho

professor

Keimyung University Dongsan Medical Center

研究点 (1)

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