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临床试验/NCT05250557
NCT05250557招募中不适用

Prognostic Impact of Lesion-specific Hemodynamic Index and Disease Characteristics in Patients With Coronary Artery Disease Assessed by Fractional Flow Reserve

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 2,429 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,429
试验地点
1
主要终点
Adverse cardiovascular event according to ΔFFR (Deferral of PCI group)

研究概览

简要总结

The investigators aim to investigate the additive prognostic value of lesion-specific hemodynamic index such as ΔFFR, non-hyperemic pressure ratio such as RFR, over % diameter stenosis and FFR according to treatment strategy, and to find the prognostic implications of post-PCI FFR after adjustment of various clinical and disease characteristics, and to construct a comprehensive risk prediction model for post-PCI outcomes.

详细描述

Fractional flow reserve (FFR)-based revascularization is the currently best practice recommended by guidelines. In addition to the use of coronary physiological indices as a vessel-specific metric, recent studies suggested the clinical importance of local hemodynamics in prediction of risk for target vessel failure or acute coronary syndrome in patients with coronary artery disease. In patients who receive percutaneous coronary intervention (PCI), the absolute value and pattern of FFR change after stenting are helpful in defining the additional target for PCI and risk stratification after PCI. However, there has been no prospective study that proved the benefit of change in FFR across the lesion (ΔFFR) in daily clinical practice, and FFR usage after stenting is much less than before stenting. Accordingly, we will prove the benefit of ΔFFR in addition to FFR, prognostic implications of combining RFR and FFR, and the comprehensive risk model with post-PCI FFR, clinical and disease characteristics in a prospective study, to maximize the benefit of invasive physiologic assessment.

研究设计

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

入排标准

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

入选标准

  • Age ≥20 years
  • All comers who underwent successful FFR measurement and pullback tracing

排除标准

  • Chronic renal failure (estimated glomerular filtration rate <30)
  • ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery history
  • Primary myocardial or valvular disease
  • Left ventricular ejection fraction < 30%
  • Hemodynamically unstable clinical conditions
  • Life expectancy < 2 years

结局指标

主要结局

Adverse cardiovascular event according to ΔFFR (Deferral of PCI group)

时间窗: Upto 2 years after index procedure

Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death

Adverse cardiovascular event according to post-PCI FFR (PCI group)

时间窗: Upto 2 years after index procedure

Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death

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

Bon-Kwon Koo

Professor

Seoul National University Hospital

研究点 (1)

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