Dedinje FFR/QFR Registry

Last updated: October 24, 2024
Sponsor: Institute for Cardiovascular Diseases Dedinje
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Atherosclerosis

Chest Pain

Treatment

N/A

Clinical Study ID

NCT06659367
IRB4669
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • >18 years old

  • Had a clinically indicated FFR procedure performed (either as a planned procedure orad hoc)

Exclusion

Exclusion Criteria:

  • Declines to participate in the registry and provide informed consent

Study Design

Total Participants: 2500
Study Start date:
October 02, 2024
Estimated Completion Date:
October 02, 2034

Connect with a study center

  • Institute for Cardiovascular Diseases "Dedinje"

    Belgrade, 11040
    Serbia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.