NCT Number: NCT06659367
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Belgrade, 11040, Serbia
Location status: Recruiting
Ivan Ilic, MD, PhD
SUB_INVESTIGATOR
Milan Dobric, MD, PhD
SUB_INVESTIGATOR
Natalija Odanovic
CONTACT
Natalija Odanovic, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
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)
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)
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)
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 6 months, 1 year and annually for 5 years
All-cause death
Time frame: at 6 months, 1 year and annually for 5 years
Myocardial infarction
Time frame: at 6 months, 1 year and annually for 5 years
Cardiac death, vessel-related myocardial infarction and ischemia-driven target vessel revascularization
Time frame: 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 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)
Contact information is provided by the study sponsor or research team.
Institute for Cardiovascular Diseases Dedinje
Other
Institute for Cardiovascular Diseases "Dedinje" Fractional Flow Reserve (FFR) and Quantitative Flow Ratio (QFR) Registry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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