Ischemic Heart DiseaseQFRRegistryNCT03791788
Multicenter Registry for Angiography-Derived Quantitative Flow Ratio
An observational study of Ischemic Heart Disease, run by Samsung Medical Center at 5 sites in South Korea.
Trial summary
1. to investigate the feasibility and diagnostic performance of contrast quantitative flow ratio (QFR) for identifying the functional significance of intermediate degree stenotic lesions in all-comer patients with coronary artery disease (CAD) including presentation of acute myocardial infarction (AMI) with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- QFR assessment
- How many people
- 524 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 30 Apr 2016to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: 320 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis who underwent FFR measurement and were able to analyze QFR
Who may be able to join
- Subject must be ≥18 years
- Patients suspected with ischemic heart disease
- Patients with intermediate degree of coronary artery stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery with FFR measurement
- Patients who were able to analyze QFR
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides
Who cannot join
- Left main (LM) or right coronary artery (RCA) ostial lesion
- Severe overlap of stenotic segments
- Severe tortuosity of target vessel
- Poor angiographic image quality precluding contour detection
- No optimal images with angles ≥ 25o
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Keimyung University Dongsan Medical Center
Daegu
Inje University Ilsan Paik Hospital
Goyang-si
Chosun University Hospital
Gwangju
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: Multicenter Registry for Diagnostic Accuracy of Angiography-Derived Quantitative Flow Ratio to Evaluate the Hemodynamic Significance of Coronary Artery Stenosis
- to investigate the feasibility and diagnostic performance of contrast quantitative flow ratio (QFR) for identifying the functional significance of intermediate degree stenotic lesions in all-comer patients with coronary artery disease (CAD) including presentation of acute myocardial infarction (AMI) with non-culprit lesion.
- to compare the changes of contrast QFR and fractional flow reserve (FFR) according to severity of percent diameter stenosis (%DS)
- to evaluate prognostic implication of contrast QFR in comparison with FFR
Read the detailed description
Despite potential clinical benefits and abundant evidences of FFR-guided percutaneous coronary intervention (PCI), adoption rate of FFR is still low in real world practice, most likely due to use of additional resource and to concern about side effects of hyperemic agent. Therefore, several tools to derive FFR non-invasively has been developed based on computational fluid dynamics to overcome the limitations. One of the novel methods, the contrast quantitative flow ratio (QFR) is a computation of FFR based on 3-dimensional quantitative coronary angiography (QCA) combined with Thrombolysis in Myocardial Infarction (TIMI) frame counts adjustment without hyperemic agent infusion.
Although diagnostic performance of contrast QFR for evaluation of functional significance, using FFR as reference standard, is well validated in patients with stable ischemic heart disease (SIHD), there have been lack of evidence regarding the reliability of QFR for non-culprit stenosis in patients with AMI.
Therefore, the investigators sought to investigate the feasibility and diagnostic performance of contrast QFR for identifying the functional significance of coronary stenosis in all-comer patients with CAD. In addition, prognostic implication of contrast QFR will be also compared with that of FFR.
- Conditions
- Ischemic Heart Disease
- Being tested
- QFR assessment
- Keywords
- Stable angina, Acute Myocardial Infarction, Fractional Flow Reserve, Quantitative Flow Ratio
- Medical subject headings
- Myocardial Ischemia, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QFR assessmentDiagnostic test
QFR measurement in order to evaluate functional significance of epicardial stenosis and to compare the response of QFR for worsening stenosis severity, FFR value as reference standard
| Study group | Role | What they receive |
|---|---|---|
| QFR Group | Patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, NSTEMI (non ST-segment elevation myocardial infarction), or STEMI (ST-segment elevation myocardial infarction) with non-culprit stenosis who underwent FFR measurement and were able to analyze QFR. Receives: Diagnostic Test: QFR assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of QFR
Diagnostic accuracy of contrast QFR to predict FFR lower than 0.8
Measured: through study completion, an average of 6 months
Vessel-related composite outcome
a composite of cardiac death, vessel-related myocardial infarction, and vessel-related ischemia driven revascularization
Measured: through study completion, an average of 2 year
Secondary outcomes (3)
Sensitivity of QFR
Sensitivity of contrast QFR to predict FFR lower than 0.8
Measured: through study completion, an average of 6 months
Specificity of QFR
Specificity of contrast QFR to predict FFR lower than 0.8
Measured: through study completion, an average of 6 months
Correlation between QFR and FFR
Correlation between QFR and FFR
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start30 Apr 2016
- Primary completion1 Oct 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Inje University, Dongsan Medical Center, Chosun University Hospital
- Responsible party
- Principal investigator, Joo Myung Lee, Samsung Medical Center
- Investigators
- Joo Myung Lee, MD, MPH, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791788
- Sponsor's protocol ID
- QFR2018-11-112-002
- Acronym
- QFRRegistry
- Status last verified
- Apr 2024
- First submitted
- 28 Dec 2018
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee SH, Gim DH, Hwang D, Kim HK, Cho H, Kim SE, Cho SW, Choi KH, Park TK, Yang JH, Song YB, Doh JH, Nam CW, Hahn JY, Koo BK, Choi SH, Gwon HC, Yoon HJ, Lee JM. Artificial Intelligence-Driven Angiographic Quantification of Fractional Flow Reserve: Proof-of-Concept Validation Study. J Am Heart Assoc. 2026 Aug 20:e049331. doi: 10.1161/JAHA.125.049331. Online ahead of print.
PubMed 42622240
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Registry for Diagnostic Accuracy of Angiography-Derived Quantitative Flow Ratio to Evaluate the Hemodynamic Significance of Coronary Artery Stenosis
- ClinicalTrials.gov ID
- NCT03791788
- Acronym / sponsor ID
- QFRRegistry / QFR2018-11-112-002
- Conditions
- Ischemic Heart Disease
- Keywords
- Stable angina, Acute Myocardial Infarction, Fractional Flow Reserve, Quantitative Flow Ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Inje University, Dongsan Medical Center, Chosun University Hospital
- Study start
- 30 Apr 2016 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- to investigate the feasibility and diagnostic performance of contrast quantitative flow ratio (QFR) for identifying the functional significance of intermediate degree stenotic lesions in all-comer patients with coronary artery disease (CAD) including presentation of acute myocardial infarction (AMI) with non-culprit lesion.
- to compare the changes of contrast QFR and fractional flow reserve (FFR) according to severity of percent diameter stenosis (%DS)
- to evaluate prognostic implication of contrast QFR in comparison with FFR
Detailed description
Despite potential clinical benefits and abundant evidences of FFR-guided percutaneous coronary intervention (PCI), adoption rate of FFR is still low in real world practice, most likely due to use of additional resource and to concern about side effects of hyperemic agent. Therefore, several tools to derive FFR non-invasively has been developed based on computational fluid dynamics to overcome the limitations. One of the novel methods, the contrast quantitative flow ratio (QFR) is a computation of FFR based on 3-dimensional quantitative coronary angiography (QCA) combined with Thrombolysis in Myocardial Infarction (TIMI) frame counts adjustment without hyperemic agent infusion.
Although diagnostic performance of contrast QFR for evaluation of functional significance, using FFR as reference standard, is well validated in patients with stable ischemic heart disease (SIHD), there have been lack of evidence regarding the reliability of QFR for non-culprit stenosis in patients with AMI.
Therefore, the investigators sought to investigate the feasibility and diagnostic performance of contrast QFR for identifying the functional significance of coronary stenosis in all-comer patients with CAD. In addition, prognostic implication of contrast QFR will be also compared with that of FFR.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QFR Group | – | Diagnostic Test: QFR assessmentPatients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, NSTEMI (non ST-segment elevation myocardial infarction), or STEMI (ST-segment elevation myocardial infarction) with non-culprit stenosis who underwent FFR measurement and were able to analyze QFR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 320 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis who underwent FFR measurement and were able to analyze QFR
Key inclusion criteria (5 listed)
- Subject must be ≥18 years
- Patients suspected with ischemic heart disease
- Patients with intermediate degree of coronary artery stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery with FFR measurement
- Patients who were able to analyze QFR
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides
Key exclusion criteria (5 listed)
- Left main (LM) or right coronary artery (RCA) ostial lesion
- Severe overlap of stenotic segments
- Severe tortuosity of target vessel
- Poor angiographic image quality precluding contour detection
- No optimal images with angles ≥ 25o
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QFR assessmentQFR measurement in order to evaluate functional significance of epicardial stenosis and to compare the response of QFR for worsening stenosis severity, FFR value as reference standard | Diagnostic test | QFR Group |
Primary outcome
Diagnostic accuracy of QFR
Time frame: through study completion, an average of 6 months
Diagnostic accuracy of contrast QFR to predict FFR lower than 0.8
Vessel-related composite outcome
Time frame: through study completion, an average of 2 year
a composite of cardiac death, vessel-related myocardial infarction, and vessel-related ischemia driven revascularization
3 secondary outcomes
Sensitivity of QFR
Time frame: through study completion, an average of 6 months
Specificity of QFR
Time frame: through study completion, an average of 6 months
Correlation between QFR and FFR
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 42622240Lee SH, Gim DH, Hwang D, Kim HK, Cho H, Kim SE, Cho SW, Choi KH, Park TK, Yang JH, Song YB, Doh JH, Nam CW, Hahn JY, Koo BK, Choi SH, Gwon HC, Yoon HJ, Lee JM. Artificial Intelligence-Driven Angiographic Quantification of Fractional Flow Reserve: Proof-of-Concept Validation Study. J Am Heart Assoc. 2026 Aug 20:e049331. doi: 10.1161/JAHA.125.049331. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo Myung Lee, MD, MPH, PhD principal investigator
Samsung Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Samsung Medical Center at 5 sites in South Korea.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of QFR (time frame: through study completion, an average of 6 months). The study lists 2 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 NCT03791788, which also lists 1 linked publication.
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 17 Apr 2024.