Dedinje FFR/QFR Registry

NCT06659367 | Recruiting

• 1 other identifier: IRB4669
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease (CAD); Fractional Flow Reserve

Keywords

coronary artery disease; fractional flow reserve; quantitative flow ratio; FFR; QFR

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

Secondary Outcomes (9)

• 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)

• 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)

• Inter-observer variability

  at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)

• Intra-observer variability

  at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)

• All-cause death

  at 6 months, 1 year and annually for 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Declines to participate in the registry and provide informed consent

Sponsors & Collaborators

• Institute for Cardiovascular Diseases Dedinje: lead

Study Sites (1)

Institute for Cardiovascular Diseases "Dedinje"

Belgrade, 11040, Serbia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Natalija Odanovic, MD

CONTACT

+381654732220; natalija.odanovic@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): October 2, 2029
• Study Completion (Estimated): October 2, 2034
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)