Dedinje FFR/QFR Registry

NCT ID: NCT06659367

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-02

Study Completion Date

2034-10-02

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease (CAD) Fractional Flow Reserve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute for Cardiovascular Diseases Dedinje

OTHER

Sponsor Role lead

Responsible Party

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Natalija Odanovic

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute for Cardiovascular Diseases "Dedinje"

Belgrade, , Serbia

Site Status RECRUITING

Countries

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Serbia

Central Contacts

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Natalija Odanovic, MD

Role: CONTACT

+381654732220

Facility Contacts

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Natalija Odanovic

Role: primary

+381654732220

Other Identifiers

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IRB4669

Identifier Type: -

Identifier Source: org_study_id

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