An observational study in Coronary Artery Disease (CAD) and Fractional Flow Reserve, sponsored by Institute for Cardiovascular Diseases Dedinje. Recruiting at 1 site in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Institute for Cardiovascular Diseases Dedinje · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Institute for Cardiovascular Diseases Dedinje is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Correlation between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)
correlation coefficient (r) between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)
Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Sensitivity of Quantitative Flow Ratio (QFR)
Sensitivity of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard
Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Specificity of Quantitative Flow Ratio (QFR)
Specificity of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard
Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Positive predictive value of Quantitative Flow Ratio (QFR)
Positive predictive value of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard
Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Negative predictive value of Quantitative Flow Ratio (QFR)
Negative predictive value of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard
Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Diagnostic gray zone
Quantitative Flow Ratio (QFR) limits for achieving 95% sensitivity and specificity in comparison to Fractional Flow Reserve (FFR)
Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Diagnostic accuracy of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR)
Area under the curve (using cutoff values of \<=0.80 for both methods)
Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Diagnostic performance of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard
Sensitivity, specificity, positive predictive value and negative predictive value of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR)
Time frame: 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
Area under the curve (using cutoff values of \<=0.89 for nonhyperemic pressure ratios and \>=50% diameter stenosis for 3-dimensional Quantitative Coronary Angiography (3D-QCA)) against Fractional Flow Reserve (FFR, cutoff value \<=0.80)
Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Inter-observer variability
Coefficient of variation for repeated Quantitative Flow Ratio (QFR) computation between users, standard deviation for repeated Quantitative Flow Ratio (QFR) measurements between users, binary diagnostic classification agreement between users
Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Intra-observer variability
Coefficient of variation for repeated Quantitative Flow Ratio (QFR) computation within users, standard deviation for repeated Quantitative Flow Ratio (QFR) measurements within users, binary diagnostic classification agreement within users
Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
All-cause death
All-cause death
Time frame: at 6 months, 1 year and annually for 5 years
Myocardial infarction
Myocardial infarction
Time frame: at 6 months, 1 year and annually for 5 years
Vessel-oriented composite outcome
Cardiac death, vessel-related myocardial infarction and ischemia-driven target vessel revascularization
Time frame: at 6 months, 1 year and annually for 5 years
Change in Seattle Angina Questionnaire-7 Items Score (SAQ-7) at 6 months
Change in Seattle Angina Questionnaire-7 Items Score (SAQ-7) at 6 months from the time of the Fractional Flow Reserve (FFR) procedure. (scale 0-100, 100 = full health, 0 = worst health)
Time frame: 6 months
Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score
Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score at 6 months from the time of the Fractional Flow Reserve (FFR) procedure (scale 5-25, 5= no problems in any dimension, 25= extreme problems on all dimensions; visual analogue scale 0-100, 0= worst health possible, 100= best health possible)
Time frame: 6 months
Plan to share: No — IPD contains sensitive identifying patient information that patients are told will not be shared with anyone outside of the primary team of researchers.
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Institute for Cardiovascular Diseases Dedinje