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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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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR) | correlation coefficient (r) between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR) | at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year) |
| Sensitivity of Quantitative Flow Ratio (QFR) | Sensitivity of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard | at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year) |
| Specificity of Quantitative Flow Ratio (QFR) | Specificity of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard | at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year) |
| Positive predictive value of Quantitative Flow Ratio (QFR) | Positive predictive value of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard | at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year) |
| Negative predictive value of Quantitative Flow Ratio (QFR) | Negative predictive value of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard | at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year) |
| Diagnostic gray zone | Quantitative Flow Ratio (QFR) limits for achieving 95% sensitivity and specificity in comparison to Fractional Flow Reserve (FFR) | at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard | 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) | at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalija Odanovic, MD | Contact | +381654732220 | natalija.odanovic@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Cardiovascular Diseases "Dedinje" | Recruiting | Belgrade | 11040 | Serbia |
IPD contains sensitive identifying patient information that patients are told will not be shared with anyone outside of the primary team of researchers.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Diagnostic accuracy of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) | Area under the curve (using cutoff values of <=0.80 for both methods) | 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 | 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) | at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year) |
| Inter-observer variability | 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 | at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year) |
| Intra-observer variability | 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 | at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year) |
| All-cause death | All-cause death | at 6 months, 1 year and annually for 5 years |
| Myocardial infarction | Myocardial infarction | at 6 months, 1 year and annually for 5 years |
| Vessel-oriented composite outcome | Cardiac death, vessel-related myocardial infarction and ischemia-driven target vessel revascularization | at 6 months, 1 year and annually for 5 years |
| Change in Seattle Angina Questionnaire-7 Items Score (SAQ-7) at 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) | 6 months |
| Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score | 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) | 6 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |