Coronary Artery DiseaseNCT06153927
Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The current study evaluated the diagnostic performance for myocardial ischemia of on-site automatic CCTA-derived FFR (CT-FFR) using a commercially available workstation as compared with invasive FFR as a reference. The diagnostic performance of CT-FFR was compared to that of CCTA diameter stenosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CT-FFR
- How many people
- 332 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2022to 31 Oct 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CAD patients who underwent CCTA, invasive coronary angiography, and FFR measurement will be included in this study.
Who may be able to join
- adults aged 20 years or older
- individuals who had undergone ≥ 64 multidetector row CCTA within 90 days before invasive coronary angiography and FFR measurement
- individuals who had not experienced any clinical events or significant clinical changes between the time of CCTA and invasive coronary angiography
Who cannot join
- previous coronary intervention or coronary bypass surgery in the target vessel
- invasive coronary angiography under unstable conditions
- previous myocardial infarction at target vessel territory
- congenital heart disease
- moderate or severe valvular heart disease
- previous valvular heart surgery
Show all 16Show fewer
- left ventricular ejection fraction ≤40% or left ventricular hypertrophy
- previous cardiac device implantation
- body mass index >35 kg/m2
- poor FFR tracing quality
- no information on the position of the FFR pressure wire
- heart rate ≥100 beats/min during CCTA
- CCTA calcium score ≥1000
- no nitroglycerin prior to CCTA
- CCTA slice thickness >1.0 mm
- significant artifacts in CCTA
Trial locations and contacts
1 site in 1 country.
About this study
The current study evaluated the diagnostic performance for myocardial ischemia of on-site automatic CCTA-derived FFR (CT-FFR) using a commercially available workstation as compared with invasive FFR as a reference. The diagnostic performance of CT-FFR was compared to that of CCTA diameter stenosis.
Read the detailed description
This is a retrospective, multicenter, comparative, investigator-initiated study to evaluate the diagnostic performance of CT-FFR from routinely acquired CCTA data using the software HeartMedi+ 1.0 (AI Medic, Korea) to detect hemodynamically significant CAD. Patients who underwent CCTA within 90 days before invasive coronary angiography and FFR measurement will be screened in each participating center. After that, invasive coronary angiography, FFR data, and CCTA data will be anonymized and transferred to the independent core laboratories and analyzed in a blind fashion.
The presence of ischemia was defined as FFR ≤0.80. Anatomical obstructive stenosis was defined as diameter stenosis on CCTA ≥50%, and the diagnostic performance of CT-FFR and CCTA stenosis for ischemia was compared.
- Conditions
- Coronary Artery Disease
- Being tested
- CT-FFR
- Keywords
- Computed Tomography-based Fractional Flow Reserve, Coronary Computed Tomography Angiography, Fractional Flow Reserve, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-FFRDiagnostic test
CT-FFR was calculated using HeartMedi+ 1.0 according to the manufacturer's instructions
| Study group | Role | What they receive |
|---|---|---|
| Patients with CCTA and FFR assessment | Patients with CAD who underwent CCTA, invasive coronary angiography, and FFR measurement will be included in this study. Receives: Diagnostic Test: CT-FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CT-FFR
Diagnostic accuracy of CT-FFR to detect hemodynamically significant CAD evaluated with an invasive FFR
Measured: At the time of test
Secondary outcomes (4)
Spearman's correlation coefficient of CT-FFR with FFR
Spearman's correlation coefficient of CT-FFR with FFR
Measured: At the time of test
Agreement between CT-FFR and FFR
Bland-Altman analysis was used to demonstrate the agreement between CT-FFR and FFR.
Measured: At the time of test
Comparison of diagnostic performance of CT-FFR to that of CCTA stenosis
Diagnostic performance to predict hemodynamically significant CAD included diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value.
A comparison of diagnostic performance was performed using McNemar's test or weight generalized score statistic as appropriate.
Measured: At the time of test
Comparison of discriminant ability of CT-FFR to that of CCTA stenosis
Discriminant ability to predict hemodynamically significant CAD was assessed by the area under the receiver-operating characteristic curve (AUC).
The AUCs were compared by Delong's test
Measured: At the time of test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start26 May 2022
- Primary completion30 Jul 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Keimyung University Dongsan Medical Center, Inje University Ilsan Paik Hospital, Chosun University Hospital, Severance Hospital
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153927
- Sponsor's protocol ID
- D-2207-023-1337
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT06153927
- Acronym / sponsor ID
- D-2207-023-1337
- Conditions
- Coronary Artery Disease
- Keywords
- Computed Tomography-based Fractional Flow Reserve, Coronary Computed Tomography Angiography, Fractional Flow Reserve, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Keimyung University Dongsan Medical Center, Inje University Ilsan Paik Hospital, Chosun University Hospital, Severance Hospital
- Study start
- 26 May 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 1 Dec 2023 (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 current study evaluated the diagnostic performance for myocardial ischemia of on-site automatic CCTA-derived FFR (CT-FFR) using a commercially available workstation as compared with invasive FFR as a reference. The diagnostic performance of CT-FFR was compared to that of CCTA diameter stenosis.
Detailed description
This is a retrospective, multicenter, comparative, investigator-initiated study to evaluate the diagnostic performance of CT-FFR from routinely acquired CCTA data using the software HeartMedi+ 1.0 (AI Medic, Korea) to detect hemodynamically significant CAD. Patients who underwent CCTA within 90 days before invasive coronary angiography and FFR measurement will be screened in each participating center. After that, invasive coronary angiography, FFR data, and CCTA data will be anonymized and transferred to the independent core laboratories and analyzed in a blind fashion.
The presence of ischemia was defined as FFR ≤0.80. Anatomical obstructive stenosis was defined as diameter stenosis on CCTA ≥50%, and the diagnostic performance of CT-FFR and CCTA stenosis for ischemia was compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CCTA and FFR assessment | – | Diagnostic Test: CT-FFRPatients with CAD who underwent CCTA, invasive coronary angiography, and FFR measurement will be included in this study. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CAD patients who underwent CCTA, invasive coronary angiography, and FFR measurement will be included in this study.
Key inclusion criteria (3 listed)
- adults aged 20 years or older
- individuals who had undergone ≥ 64 multidetector row CCTA within 90 days before invasive coronary angiography and FFR measurement
- individuals who had not experienced any clinical events or significant clinical changes between the time of CCTA and invasive coronary angiography
Key exclusion criteria (16 listed)
- previous coronary intervention or coronary bypass surgery in the target vessel
- invasive coronary angiography under unstable conditions
- previous myocardial infarction at target vessel territory
- congenital heart disease
- moderate or severe valvular heart disease
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 |
|---|---|---|
| CT-FFRCT-FFR was calculated using HeartMedi+ 1.0 according to the manufacturer's instructions | Diagnostic test | Patients with CCTA and FFR assessment |
Primary outcome
Diagnostic accuracy of CT-FFR
Time frame: At the time of test
Diagnostic accuracy of CT-FFR to detect hemodynamically significant CAD evaluated with an invasive FFR
4 secondary outcomes
Spearman's correlation coefficient of CT-FFR with FFR
Time frame: At the time of test
Agreement between CT-FFR and FFR
Time frame: At the time of test
Comparison of diagnostic performance of CT-FFR to that of CCTA stenosis
Time frame: At the time of test
Comparison of discriminant ability of CT-FFR to that of CCTA stenosis
Time frame: At the time of test
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 1 Dec 2023.
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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.
Bon-Kwon Koo, MD, PhD principal investigator
Seoul National University 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 Coronary Artery Disease, run by Seoul National University 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 3 inclusion and 16 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 1 Dec 2023. 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 of CT-FFR (time frame: At the time of test). 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 1 Dec 2023.