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NCT Number: NCT06659367

Dedinje FFR/QFR Registry

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.

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Fractional Flow Reserve Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Cardiovascular Diseases "Dedinje"

Belgrade, 11040, Serbia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

    correlation coefficient (r) between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)

  2. Sensitivity of Quantitative Flow Ratio (QFR)

    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

  3. Specificity 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) against Fractional Flow Reserve (FFR) as the gold standard

  4. Positive predictive value 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) against Fractional Flow Reserve (FFR) as the gold standard

  5. Negative 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) against Fractional Flow Reserve (FFR) as the gold standard

  6. Diagnostic gray zone

    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)

  7. 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)

    Area under the curve (using cutoff values of <=0.80 for both methods)

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

    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)

  2. 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)

    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)

  3. Inter-observer variability

    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

  4. Intra-observer variability

    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

  5. All-cause death

    Time frame: at 6 months, 1 year and annually for 5 years

    All-cause death

  6. Myocardial infarction

    Time frame: at 6 months, 1 year and annually for 5 years

    Myocardial infarction

  7. Vessel-oriented composite outcome

    Time frame: at 6 months, 1 year and annually for 5 years

    Cardiac death, vessel-related myocardial infarction and ischemia-driven target vessel revascularization

  8. Change in Seattle Angina Questionnaire-7 Items Score (SAQ-7) at 6 months

    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)

  9. Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score

    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)

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Sponsors and collaborators

Lead sponsor

Institute for Cardiovascular Diseases Dedinje

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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