Clinical trial NCT06659367: Dedinje FFR/QFR Registry
Official title: Institute for Cardiovascular Diseases "Dedinje" Fractional Flow Reserve (FFR) and Quantitative Flow Ratio (QFR) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease (CAD)
Fractional Flow Reserve
Keywords: coronary artery disease
fractional flow reserve
quantitative flow ratio
FFR
QFR
Lead sponsor: Institute for Cardiovascular Diseases Dedinje
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: Inclusion Criteria:

* \>18 years old
* Had a clinically indicated FFR procedure performed (either as a planned procedure or ad hoc)

Exclusion Criteria:

* Declines to participate in the registry and provide informed consent

Primary outcomes:
measure: Correlation between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)
timeFrame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
measure: Sensitivity of Quantitative Flow Ratio (QFR)
timeFrame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
measure: Specificity of Quantitative Flow Ratio (QFR)
timeFrame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
measure: Positive predictive value of Quantitative Flow Ratio (QFR)
timeFrame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
measure: Negative predictive value of Quantitative Flow Ratio (QFR)
timeFrame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
measure: Diagnostic gray zone
timeFrame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
measure: Diagnostic accuracy of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR)
timeFrame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
Secondary outcomes:
measure: Diagnostic performance of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard
timeFrame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
measure: Diagnostic accuracy of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard
timeFrame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
measure: Inter-observer variability
timeFrame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
measure: Intra-observer variability
timeFrame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)
measure: All-cause death
timeFrame: at 6 months, 1 year and annually for 5 years
measure: Myocardial infarction
timeFrame: at 6 months, 1 year and annually for 5 years
measure: Vessel-oriented composite outcome
timeFrame: at 6 months, 1 year and annually for 5 years
measure: Change in Seattle Angina Questionnaire-7 Items Score (SAQ-7) at 6 months
timeFrame: 6 months
measure: Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score
timeFrame: 6 months
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Institute for Cardiovascular Diseases "Dedinje"
Study officials:
References: