跳至主要内容
临床试验/NCT06322355
NCT06322355已完成不适用

Comparison of Flow Ratio Derived From Intravascular Ultrasound With Coronary Angiography in Stable Coronary Artery Disease: Correlation With Fractional Flow Reserve

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
试验地点
1
主要终点
Compare diagnostic performance of QFR with UFR

研究概览

简要总结

Quantitative flow reserve (QFR), derived from coronary angiography, has shown high accuracy in detecting significant lesions. Ultrasonic flow ratio (UFR), a new development from IVUS, integrates physiological estimation with intravascular imaging. Although both QFR and UFR are effective, there's no conclusive evidence favoring one over the other. The study aims to compare UFR and QFR's diagnostic performance against the conventional FFR standard in detecting significant coronary lesions.

详细描述

Coronary artery disease (CAD) remains a prevalent global health concern, necessitating precise diagnostic strategies for optimal patient management. Fractional Flow Reserve (FFR), defined as the distal-to-proximal pressure ratio across a coronary stenosis during maximal hyperemia and typically measured by a pressure guidewire during coronary angiography (CAG), is considered a gold standard tool for detecting ischemia-causing stenosis and guiding revascularization decisions. However, wire-based FFR has been significantly underutilized due to practical reasons, including its invasive nature and the requirement for hyperemia. Consequently, there is growing interest in developing and validating computational FFR from anatomical information derived from CAG and intravascular imaging modalities, such as intravascular ultrasound (IVUS).

Quantitative flow reserve (QFR), derived from CAG, has been extensively investigated and has demonstrated high diagnostic performance for detecting hemodynamically significant lesions. Beyond CAG, research has indicated that IVUS imaging can also be utilized for computing FFR. IVUS, a widely accepted and powerful modality for evaluating vessel luminal size and characterizing plaque morphology in the context of coronary intervention, has given rise to IVUS-based FFR, known as ultrasonic flow ratio (UFR). UFR has been recently developed, integrating an estimation of physiology with intravascular imaging in the same IVUS pullback. Despite the proven effectiveness of both UFR and QFR, there is currently no evidence supporting the superiority of one technique over the other. In the present study, investigators aim to compare the diagnostic performance of UFR and QFR for the detection of functionally significant coronary lesions, using conventional FFR as the gold standard.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who underwent both IVUS imaging and FFR measurement on the same artery

排除标准

  • Inadequate quality of CAG or IVUS images for QFR or UFR calculation
  • Left main or ostial right coronary artery lesion
  • The use of balloon predilatation or stent placement prior to FFR measurement or IVUS imaging
  • Incomplete IVUS pullback across the entire lesion segment
  • The presence of a severe myocardial bridge (defined as ≥30% systolic diameter stenosis) in the examined vessel
  • History of previous coronary artery bypass grafting,
  • Left ventricular ejection fraction <35%

结局指标

主要结局

Compare diagnostic performance of QFR with UFR

时间窗: baseline

次要结局

  • Correlation and agreement between QFR and UFR(baseline)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Junbo Ge

Professor

Shanghai Zhongshan Hospital

研究点 (1)

Loading locations...

相似试验