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Recruiting NCT06659367

Dedinje FFR/QFR Registry

— Observational Coronary Artery Disease (CAD) Fractional Flow Reserve

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Artery Disease (CAD), Fractional Flow Reserve. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Serbia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Institute for Cardiovascular Diseases "Dedinje" Fractional Flow Reserve (FFR) and Quantitative Flow Ratio (QFR) Registry

Overview

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.

Primary outcome measures

  • Correlation 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) [Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Specificity of Quantitative Flow Ratio (QFR) [Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Positive predictive value of Quantitative Flow Ratio (QFR) [Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Negative predictive value of Quantitative Flow Ratio (QFR) [Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Diagnostic gray zone [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) [Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
Secondary outcome measures (9)
  • Diagnostic performance of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) 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 accuracy of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) 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)]
  • Inter-observer variability [Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • Intra-observer variability [Time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)]
  • 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]
  • Vessel-oriented composite outcome [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 [Time frame: 6 months]
  • Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Serbia · 1 center
  • Institute for Cardiovascular Diseases "Dedinje" — Belgrade

Identifiers

NCT: NCT06659367 · IRB4669

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗