Institute for Cardiovascular Diseases "Dedinje" Fractional Flow Reserve (FFR) and Quantitative Flow Ratio (QFR) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Correlation between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)
研究概览
简要总结
Quantitative Flow Ratio (QFR) has shown good diagnostic performance against Fractional Flow Reserve (FFR) in several meta-analyses, comparable or even superior to nonhyperemic pressure ratios. However, the reproducibility of QFR is modest and there is high inter- and intra-observer variability even when fairly experienced but non-core lab operators (at least 150 QFR procedure experience) are performing the analysis. Although smaller studies have demonstrated that non-core analysis and even paramedical user analysis can have good correlation with FFR, the concern about the diagnostic performance of QFR in real-world clinical practice by inexperienced users remains.
The primary objective of "Dedinje FFR/QFR Registry" is to determine the feasibility and diagnostic performance of QFR analysis by vendor-certified inexperienced medical users in a real-world setting using FFR as the gold standard. All patients >18 years old who present to the Institute for Cardiovascular Diseases "Dedinje" and undergo a planned or ad hoc FFR procedure will be asked to participate in the registry. FFR procedure is performed according to the standardized institutional protocol. QFR analysis will be subsequently performed offline according to a standard operating procedure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •Had a clinically indicated FFR procedure performed (either as a planned procedure or ad hoc)
排除标准
- •Declines to participate in the registry and provide informed consent
结局指标
主要结局
Correlation between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)
时间窗: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
correlation coefficient (r) between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)
Sensitivity of Quantitative Flow Ratio (QFR)
时间窗: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Sensitivity of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard
Specificity of Quantitative Flow Ratio (QFR)
时间窗: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Specificity of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard
Positive predictive value of Quantitative Flow Ratio (QFR)
时间窗: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Positive predictive value of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard
Negative predictive value of Quantitative Flow Ratio (QFR)
时间窗: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Negative predictive value of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard
Diagnostic gray zone
时间窗: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Quantitative Flow Ratio (QFR) limits for achieving 95% sensitivity and specificity in comparison to Fractional Flow Reserve (FFR)
Diagnostic accuracy of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR)
时间窗: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Area under the curve (using cutoff values of \<=0.80 for both methods)
次要结局
- Diagnostic performance of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard(at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year))
- Diagnostic accuracy of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard(at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year))
- Inter-observer variability(at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year))
- Intra-observer variability(at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year))
- All-cause death(at 6 months, 1 year and annually for 5 years)
- Myocardial infarction(at 6 months, 1 year and annually for 5 years)
- Vessel-oriented composite outcome(at 6 months, 1 year and annually for 5 years)
- Change in Seattle Angina Questionnaire-7 Items Score (SAQ-7) at 6 months(6 months)
- Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score(6 months)
研究者
Natalija Odanovic
Principal Investigator
Institute for Cardiovascular Diseases Dedinje