| NCT ID | NCT06659367 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute for Cardiovascular Diseases Dedinje |
| Condition | Coronary Artery Disease (CAD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2024-10-02 |
| Primary Completion | 2029-10-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2024-10-02 with a primary completion date of 2029-10-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06659367 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06659367 currently recruiting?
Yes, NCT06659367 is actively recruiting participants. Contact the research team at natalija.odanovic@gmail.com for enrollment information.
Where is the NCT06659367 trial being conducted?
This trial is being conducted at Belgrade, Serbia.
Who is sponsoring the NCT06659367 clinical trial?
NCT06659367 is sponsored by Institute for Cardiovascular Diseases Dedinje. The trial plans to enroll 2,500 participants.