Dedinje FFR/QFR Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute for Cardiovascular Diseases Dedinje
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>18 years old
Had a clinically indicated FFR procedure performed (either as a planned procedure or ad hoc)
Disqualifiers
Declines to participate in the registry and provide informed consent
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov