The Catholic Imaging and Functional Research Cohort (C-iFR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 915
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR
研究概览
简要总结
- The primary technical endpoint was the diagnostic performance of the QFR against the FFR.
- The primary clinical endpoint was target vessel failure (TVF) between two groups distributed by a QFR cut-off value of 0.8
详细描述
The quantitative flow ratio (QFR) is a novel angiography-based tool used to assess functional ischemia caused by coronary stenosis. Computation of the fractional flow reserve (FFR) from coronary angiography is based on 3D reconstruction and fluid dynamics algorithms using a modified frame count; therefore, we do not need to induce hyperemia or perform invasive procedures with a pressure wire to measure it. During the past few years, the diagnostic accuracy of the QFR was investigated and showed favorable outcomes. However, data for patients with acute coronary syndrome are lacking. In addition, no data are available for the performance of the QFR in predicting clinical outcomes. We aim to evaluate the diagnostic performance of the QFR versus the FFR and their predictive abilities for clinical outcome in a real-world all-comer population.
The Catholic imaging and Functional Research (C-iFR) Cohort was designed to evaluate the diagnostic performance and clinical outcome predictive ability of the QFR in consecutive patients undergoing CAG and the FFR at 4 major cardiac centers in Korea from January 2012 to May 2018. All hospitals (Seoul St. Mary's Hospital, Seoul; St. Paul's Hospital, Seoul; Incheon St. Mary's Hospital, Incheon; Uijeongbu St. Mary's Hospital, Uijeongbu) perform a high volume of percutaneous coronary intervention (PCI) procedures, with more than 800 PCI procedures performed per year. This QFR registry includes demographic characteristics, clinical information, laboratory data, QFR findings, and FFR findings, with clinical outcome data collected over 4 years (a median of 2 years)
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
- 否
入选标准
- •subject ≥18 years
- •Patients suspected with ischemic heart disease
- •All-comer patients with SA, UA and AMI whose CAG results showed intermediate stenosis (50-70%) indicative of physiologic lesions
- •Patients whose target vessels were able to analyze QFR
排除标准
- •Patients with insufficient CAG data due to reasons below
- •CAG data uploading error
- •2 projection angles <25 degrees apart
- •only 1 projection angle image exists
- •images with suboptimal contrast filling
- •images with too much panning or too much magnification
- •containing an ostial lesion of the left main coronary artery or right coronary artery
- •anatomical vessel problems including severe overlap, severe tortuosity, foreshortening, diffuse lesions, additional far distal lesion
结局指标
主要结局
Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR
时间窗: follow up of 4 years (anticipated median duration : 2 years)
the diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of the QFR≤0.80 for identifying an FFR≤0.8 as the reference standard
Target vessel failure
时间窗: follow up of 4 years (anticipated median duration : 2 years)
target vessel failure (TVF) between two groups distributed by a QFR cut-off value of 0.8
次要结局
- All-cause death, cardiac death, nonfatal myocardial infarction, TLR and stroke(follow up of 4 years (anticipated median duration : 2 years))
- Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with complicated coronary lesions(follow up of 4 years (anticipated median duration : 2 years))
- Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with a borderline FFR (≥0.75, ≤0.85)(follow up of 4 years (anticipated median duration : 2 years))
研究者
Kiyuk Chang
Prof.
Seoul St. Mary's Hospital