Ischemic Heart DiseaseNCT04102917
Diagnostic Performance and Prognostic Ability of the QFR
An observational study of Ischemic Heart Disease, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
1. The primary technical endpoint was the diagnostic performance of the QFR against the FFR. 2. The primary clinical endpoint was target vessel failure (TVF) between two groups distributed by a QFR cut-off value of 0.8 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
- 915 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2012to 14 Jun 2019
- 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: 915 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, acute myocardial infarction with non-culprit stenotic lesion who underwent FFR measurement and were able to analyze QFR
Who may be able to join
- subject ≥18 years
- Patients suspected with ischemic heart disease
- All-comer patients with SA, UA and AMI whose CAG results showed intermediate stenosis (50-70%) indicative of physiologic lesions
- Patients whose target vessels were able to analyze QFR
- Exclusion Criteria: Patients with insufficient CAG data due to reasons below
- CAG data uploading error
Show all 12Show fewer
- 2 projection angles <25 degrees apart
- only 1 projection angle image exists
- images with suboptimal contrast filling
- images with too much panning or too much magnification
- containing an ostial lesion of the left main coronary artery or right coronary artery
- anatomical vessel problems including severe overlap, severe tortuosity, foreshortening, diffuse lesions, additional far distal lesion
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Catholic Imaging and Functional Research Cohort (C-iFR)
- The primary technical endpoint was the diagnostic performance of the QFR against the FFR.
- The primary clinical endpoint was target vessel failure (TVF) between two groups distributed by a QFR cut-off value of 0.8
Read the detailed description
The quantitative flow ratio (QFR) is a novel angiography-based tool used to assess functional ischemia caused by coronary stenosis. Computation of the fractional flow reserve (FFR) from coronary angiography is based on 3D reconstruction and fluid dynamics algorithms using a modified frame count; therefore, we do not need to induce hyperemia or perform invasive procedures with a pressure wire to measure it. During the past few years, the diagnostic accuracy of the QFR was investigated and showed favorable outcomes. However, data for patients with acute coronary syndrome are lacking. In addition, no data are available for the performance of the QFR in predicting clinical outcomes. We aim to evaluate the diagnostic performance of the QFR versus the FFR and their predictive abilities for clinical outcome in a real-world all-comer population.
The Catholic imaging and Functional Research (C-iFR) Cohort was designed to evaluate the diagnostic performance and clinical outcome predictive ability of the QFR in consecutive patients undergoing CAG and the FFR at 4 major cardiac centers in Korea from January 2012 to May 2018. All hospitals (Seoul St. Mary's Hospital, Seoul; St. Paul's Hospital, Seoul; Incheon St. Mary's Hospital, Incheon; Uijeongbu St. Mary's Hospital, Uijeongbu) perform a high volume of percutaneous coronary intervention (PCI) procedures, with more than 800 PCI procedures performed per year. This QFR registry includes demographic characteristics, clinical information, laboratory data, QFR findings, and FFR findings, with clinical outcome data collected over 4 years (a median of 2 years)
- Conditions
- Ischemic Heart Disease
- Being tested
- QFR assessment
- Keywords
- QFR, quantitative flow ratio
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QFR assessmentDiagnostic test
The quantitative flow ratio (QFR) is a novel angiography-based method for noninvasive functional assessment of intermediate coronary lesions.
| Study group | Role | What they receive |
|---|---|---|
| QFR group | 915 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, acute 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, sensitivity, specificity, negative predictive value, positive predictive value of QFR
the diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of the QFR≤0.80 for identifying an FFR≤0.8 as the reference standard
Measured: follow up of 4 years (anticipated median duration : 2 years)
Target vessel failure
target vessel failure (TVF) between two groups distributed by a QFR cut-off value of 0.8
Measured: follow up of 4 years (anticipated median duration : 2 years)
Secondary outcomes (3)
Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with a borderline FFR (≥0.75, ≤0.85)
the sensitivity, specificity, negative predictive value, positive predictive value of the QFR≤0.80 for identifying an FFR≤0.8 as the reference standard in subgroups with a borderline FFR (≥0.75, ≤0.85)
Measured: follow up of 4 years (anticipated median duration : 2 years)
Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with complicated coronary lesions
the sensitivity, specificity, negative predictive value, positive predictive value of the QFR≤0.80 for identifying an FFR≤0.8 as the reference standard in subgroups with complicated coronary lesions, such as bifurcation lesions, a large intraluminal plaque volume, a low mean flow rate, a long lesion length, calcification, tandem lesions, and a previous history of coronary intervention
Measured: follow up of 4 years (anticipated median duration : 2 years)
All-cause death, cardiac death, nonfatal myocardial infarction, TLR and stroke
all-cause death, cardiac death, nonfatal myocardial infarction, TLR and stroke between two groups distributed by a QFR cut-off value of 0.80
Measured: follow up of 4 years (anticipated median duration : 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Jan 2012
- Primary completion31 May 2018
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 915 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea, Seoul Saint Mary's Hospital, Incheon Saint Mary's Hospital, Seoul Saint Paul's Hospital, Uijeongbu Saint Mary's Hospital
- Responsible party
- Principal investigator, Kiyuk Chang, Seoul St. Mary's Hospital
- Investigators
- Kiyuk Chang, MD, PhD, Principal investigator, Seoul Saint Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102917
- Sponsor's protocol ID
- XC18REDI0035
- Status last verified
- Sep 2019
- First submitted
- 15 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Catholic Imaging and Functional Research Cohort (C-iFR)
- ClinicalTrials.gov ID
- NCT04102917
- Acronym / sponsor ID
- XC18REDI0035
- Conditions
- Ischemic Heart Disease
- Keywords
- QFR, quantitative flow ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 915 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea, Seoul Saint Mary's Hospital, Incheon Saint Mary's Hospital, Seoul Saint Paul's Hospital, Uijeongbu Saint Mary's Hospital
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 25 Sep 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.
- The primary technical endpoint was the diagnostic performance of the QFR against the FFR.
- The primary clinical endpoint was target vessel failure (TVF) between two groups distributed by a QFR cut-off value of 0.8
Detailed description
The quantitative flow ratio (QFR) is a novel angiography-based tool used to assess functional ischemia caused by coronary stenosis. Computation of the fractional flow reserve (FFR) from coronary angiography is based on 3D reconstruction and fluid dynamics algorithms using a modified frame count; therefore, we do not need to induce hyperemia or perform invasive procedures with a pressure wire to measure it. During the past few years, the diagnostic accuracy of the QFR was investigated and showed favorable outcomes. However, data for patients with acute coronary syndrome are lacking. In addition, no data are available for the performance of the QFR in predicting clinical outcomes. We aim to evaluate the diagnostic performance of the QFR versus the FFR and their predictive abilities for clinical outcome in a real-world all-comer population.
The Catholic imaging and Functional Research (C-iFR) Cohort was designed to evaluate the diagnostic performance and clinical outcome predictive ability of the QFR in consecutive patients undergoing CAG and the FFR at 4 major cardiac centers in Korea from January 2012 to May 2018. All hospitals (Seoul St. Mary's Hospital, Seoul; St. Paul's Hospital, Seoul; Incheon St. Mary's Hospital, Incheon; Uijeongbu St. Mary's Hospital, Uijeongbu) perform a high volume of percutaneous coronary intervention (PCI) procedures, with more than 800 PCI procedures performed per year. This QFR registry includes demographic characteristics, clinical information, laboratory data, QFR findings, and FFR findings, with clinical outcome data collected over 4 years (a median of 2 years)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QFR group | – | Diagnostic Test: QFR assessment915 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, acute 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
- 915 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, acute myocardial infarction with non-culprit stenotic lesion who underwent FFR measurement and were able to analyze QFR
Key inclusion criteria (12 listed)
- subject ≥18 years
- Patients suspected with ischemic heart disease
- All-comer patients with SA, UA and AMI whose CAG results showed intermediate stenosis (50-70%) indicative of physiologic lesions
- Patients whose target vessels were able to analyze QFR
- Exclusion Criteria: Patients with insufficient CAG data due to reasons below
Key exclusion criteria (0 listed)
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 assessmentThe quantitative flow ratio (QFR) is a novel angiography-based method for noninvasive functional assessment of intermediate coronary lesions. | Diagnostic test | QFR group |
Primary outcome
Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR
Time frame: follow up of 4 years (anticipated median duration : 2 years)
the diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of the QFR≤0.80 for identifying an FFR≤0.8 as the reference standard
Target vessel failure
Time frame: follow up of 4 years (anticipated median duration : 2 years)
target vessel failure (TVF) between two groups distributed by a QFR cut-off value of 0.8
3 secondary outcomes
Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with a borderline FFR (≥0.75, ≤0.85)
Time frame: follow up of 4 years (anticipated median duration : 2 years)
Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with complicated coronary lesions
Time frame: follow up of 4 years (anticipated median duration : 2 years)
All-cause death, cardiac death, nonfatal myocardial infarction, TLR and stroke
Time frame: follow up of 4 years (anticipated median duration : 2 years)
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 25 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Ischemic Heart Disease
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
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.
Kiyuk Chang, MD, PhD principal investigator
Seoul Saint Mary's Hospital
1 site 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 Seoul St. Mary's Hospital at 1 site 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 12 inclusion and 0 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 25 Sep 2019. 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 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, sensitivity, specificity, negative predictive value, positive predictive value of QFR (time frame: follow up of 4 years (anticipated median duration : 2 years)). 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?
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 25 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.