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Coronary Artery Disease (CAD)NCT06659367

Dedinje FFR/QFR Registry

An observational study of Coronary Artery Disease (CAD) and Fractional Flow Reserve, run by Institute for Cardiovascular Diseases Dedinje at 1 site in Serbia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
2,500 participants
Where
1 siteSerbia
Study dates
2 Oct 2024to 2 Oct 2034
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Declines to participate in the registry and provide informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Natalija Odanovic, MD contact

+381654732220

natalija.odanovic@gmail.com

Serbia1 site, 1 recruiting

  • Institute for Cardiovascular Diseases "Dedinje"

    Belgrade, 11040

    Natalija Odanovic, +381654732220, natalija.odanovic@gmail.com

    Natalija Odanovic, MD

    Recruiting

Other trials in Serbia

About this study

Official title: Institute for Cardiovascular Diseases "Dedinje" Fractional Flow Reserve (FFR) and Quantitative Flow Ratio (QFR) Registry

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.

Keywords
coronary artery disease, fractional flow reserve, quantitative flow ratio, FFR, QFR
Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)

    correlation coefficient (r) between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)

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

  2. Sensitivity of Quantitative Flow Ratio (QFR)

    Sensitivity of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard

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

  3. Specificity of Quantitative Flow Ratio (QFR)

    Specificity of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard

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

  4. 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

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

  5. 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

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

  6. Diagnostic gray zone

    Quantitative Flow Ratio (QFR) limits for achieving 95% sensitivity and specificity in comparison to Fractional Flow Reserve (FFR)

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

  7. 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)

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

Secondary outcomes (9)

  1. 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)

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

  2. 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)

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

  3. 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

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

  4. 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

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

  5. All-cause death

    All-cause death

    Measured: at 6 months, 1 year and annually for 5 years

  6. Myocardial infarction

    Myocardial infarction

    Measured: at 6 months, 1 year and annually for 5 years

  7. Vessel-oriented composite outcome

    Cardiac death, vessel-related myocardial infarction and ischemia-driven target vessel revascularization

    Measured: at 6 months, 1 year and annually for 5 years

  8. 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)

    Measured: 6 months

  9. 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)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2024
  2. Study start2 Oct 2024
  3. Primary completion2 Oct 2029 (estimated)
  4. Study completion2 Oct 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06659367
Sponsor's protocol ID
IRB4669
Status last verified
Oct 2024
First submitted
23 Oct 2024
Last updated
26 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD contains sensitive identifying patient information that patients are told will not be shared with anyone outside of the primary team of researchers.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease (CAD) and Fractional Flow Reserve, run by Institute for Cardiovascular Diseases Dedinje at 1 site in Serbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Natalija Odanovic, MD (+381654732220, natalija.odanovic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR) (time frame: at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06659367.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.

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