Coronary Artery Disease (CAD), Fractional Flow Reserve
Conditions
Keywords
coronary artery disease, fractional flow reserve, quantitative flow ratio, FFR, QFR
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.
Interventions
None listed
Sponsors
Institute for Cardiovascular Diseases Dedinje
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR) | 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) |
| Sensitivity of Quantitative Flow Ratio (QFR) | 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 |
| Specificity of Quantitative Flow Ratio (QFR) | 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 |
| Positive predictive value of Quantitative Flow Ratio (QFR) | 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 |
| Negative predictive value of Quantitative Flow Ratio (QFR) | 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 |
| Diagnostic gray zone | 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) |
| Diagnostic accuracy of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Seattle Angina Questionnaire-7 Items Score (SAQ-7) at 6 months | 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) |
| Diagnostic performance of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard | 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) |
| Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score | 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) |
| Diagnostic accuracy of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard | 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) |
| Inter-observer variability | 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 |
| Intra-observer variability | 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 |
| All-cause death | at 6 months, 1 year and annually for 5 years | All-cause death |
| Myocardial infarction | at 6 months, 1 year and annually for 5 years | Myocardial infarction |
| Vessel-oriented composite outcome | at 6 months, 1 year and annually for 5 years | Cardiac death, vessel-related myocardial infarction and ischemia-driven target vessel revascularization |
Countries
Serbia
Contacts
Primary ContactNatalija Odanovic, MD
Outcome results
None listed