Ischemic Heart DiseaseNCT05694065
Functional ComprEhensive AssessmenT by IVUS Reconstruction in Patients With Suspected IschEmic Heart Disease (FEATURE)
An observational study of Ischemic Heart Disease, run by Ruijin Hospital at 1 site in China.
Trial summary
Investigating the diagnostic accuracy of online Ultrasonic Flow Ratio (UFR) assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived fractional flow reserve (FFR) as a reference standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients with suspected ischemic heart disease who undergo coronary angiography.
Who may be able to join
- Subject must be ≥ 18 years
- Patients suspected with ischemic heart disease
- ≥ 1 diseased vessel with angiographic percent diameter stenosis between 40% and 80% in a vessel ≥ 2.5mm by visual estimation
- Target vessels are limited to major epicardial coronary arteries (left anterior descending artery [LAD], left circumflex artery [LCX], right coronary artery [RCA])
Who cannot join
- Patients with previous coronary artery bypass grafting (CABG)
- Myocardial infarction within 72h of coronary angiography
- Allergy to the contrast agent or adenosine
- Left main coronary artery stenosis ≥ 50%
- Target vessel with in-stent restenosis
- Target vessel with severe tortuosity or angulation
Show all 15Show fewer
- 100% occlusion of target vessel
- Target vessel spasm or injury
- Target vessel with severe myocardial bridge
- Target vessel with severe thrombosis
- Intravascular ultrasound (IVUS) pullback fails to cover the complete target lesion
- Presence of false lumen at target vessel based on IVUS
- A serum creatinine level >150 umol/l, or a glomerular filtration rate < 45 ml/kg/1.73 m^2
- Heart failure
- Ineligible for diagnostic intervention (IVUS or FFR examination)
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Functional ComprEhensive AssessmenT by Intravascular UltrasoUnd Reconstruction in Patients With Suspected IschEmic Coronary Artery Disease (FEATURE)
Investigating the diagnostic accuracy of online Ultrasonic Flow Ratio (UFR) assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived fractional flow reserve (FFR) as a reference standard.
Read the detailed description
- Study overview This is a prospective, single-center, observational registry study of patients with suspected ischemic coronary artery disease. The purpose of this registry is to investigate the accuracy of online UFR assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived FFR as a reference standard.
- Study population and sample size calculation are based on the diagnostic performance of previous studies, where an accuracy of 92% was found for UFR. Investigators conservatively estimate the diagnostic accuracy of online UFR assessment as 90% for consecutively enrolled patient population, and with a test target value set as 78% at a two-side significance level of 0.05, statistical power as 90%. Considering incomplete FFR/UFR data of 10% at most, a total of 112 patients need to be enrolled.
- Participant enrollment was completed in November 2024; the study is currently in the follow-up phase with ongoing data collection and analysis.
- Conditions
- Ischemic Heart Disease
- Medical subject headings
- Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Onsite UFR
UFR was computed as the pressure ratio across a coronary stenosis, using FFR ≤0.80 as the reference standard for hemodynamically significant stenosis.
The diagnostic performance of onsite UFR was assessed by the area under the receiver operating characteristic (ROC) curve analysis, with diagnostic accuracy defined as the percentage of all correctly classified cases (true positives and true negatives) in the total population.
Measured: baseline
Secondary outcomes (4)
Sensitivity of Onsite UFR
The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard.
Sensitivity was defined as the percentage of true positives correctly identified by UFR.
Measured: baseline
Specificity of Onsite UFR
The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard.
Specificity was defined as the percentage of true negatives correctly identified by UFR.
Measured: baseline
Sensitivity of Minimal Lumen Area (MLA)
The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard.
Sensitivity was defined as the percentage of true positives correctly identified by the prespecified MLA cutoff value.
Measured: baseline
Specificity of MLA
The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard.
Specificity was defined as the percentage of true negatives correctly identified by the prespecified MLA cutoff value.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start17 Feb 2023
- Primary completion22 Nov 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 Ruijin 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- School of Biomedical Engineering, Shanghai Jiao Tong University, Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Fenghua Ding, MD, PhD, Principal investigator, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694065
- Sponsor's protocol ID
- 20221110025331724
- Status last verified
- Aug 2025
- First submitted
- 12 Jan 2023
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu L, Yu L, Ding D, Huang K, Wang A, Hou X, Yu W, Zhang R, Daemen J, Ding F, Tu S. Diagnostic Accuracy of Artificial Intelligence-Enhanced Ultrasonic Flow Ratio for On-Site Assessment of Coronary Stenosis. JACC Asia. 2026 May 11:S2772-3747(26)00268-1. doi: 10.1016/j.jacasi.2026.04.011. Online ahead of print.
PubMed 42145031
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional ComprEhensive AssessmenT by Intravascular UltrasoUnd Reconstruction in Patients With Suspected IschEmic Coronary Artery Disease (FEATURE)
- ClinicalTrials.gov ID
- NCT05694065
- Acronym / sponsor ID
- 20221110025331724
- Conditions
- Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- School of Biomedical Engineering, Shanghai Jiao Tong University, Erasmus Medical Center
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Posted 24 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigating the diagnostic accuracy of online Ultrasonic Flow Ratio (UFR) assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived fractional flow reserve (FFR) as a reference standard.
Detailed description
- Study overview This is a prospective, single-center, observational registry study of patients with suspected ischemic coronary artery disease. The purpose of this registry is to investigate the accuracy of online UFR assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived FFR as a reference standard.
- Study population and sample size calculation are based on the diagnostic performance of previous studies, where an accuracy of 92% was found for UFR. Investigators conservatively estimate the diagnostic accuracy of online UFR assessment as 90% for consecutively enrolled patient population, and with a test target value set as 78% at a two-side significance level of 0.05, statistical power as 90%. Considering incomplete FFR/UFR data of 10% at most, a total of 112 patients need to be enrolled.
- Participant enrollment was completed in November 2024; the study is currently in the follow-up phase with ongoing data collection and analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected ischemic heart disease who undergo coronary angiography.
Key inclusion criteria (4 listed)
- Subject must be ≥ 18 years
- Patients suspected with ischemic heart disease
- ≥ 1 diseased vessel with angiographic percent diameter stenosis between 40% and 80% in a vessel ≥ 2.5mm by visual estimation
- Target vessels are limited to major epicardial coronary arteries (left anterior descending artery [LAD], left circumflex artery [LCX], right coronary artery [RCA])
Key exclusion criteria (15 listed)
- Patients with previous coronary artery bypass grafting (CABG)
- Myocardial infarction within 72h of coronary angiography
- Allergy to the contrast agent or adenosine
- Left main coronary artery stenosis ≥ 50%
- Target vessel with in-stent restenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of Onsite UFR
Time frame: baseline
UFR was computed as the pressure ratio across a coronary stenosis, using FFR ≤0.80 as the reference standard for hemodynamically significant stenosis. The diagnostic performance of onsite UFR was assessed by the area under the receiver operating characteristic (ROC) curve analysis, with diagnostic accuracy defined as the percentage of all correctly classified cases (true positives and true negatives) in the total population.
4 secondary outcomes
Sensitivity of Onsite UFR
Time frame: baseline
Specificity of Onsite UFR
Time frame: baseline
Sensitivity of Minimal Lumen Area (MLA)
Time frame: baseline
Specificity of MLA
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 42145031Liu L, Yu L, Ding D, Huang K, Wang A, Hou X, Yu W, Zhang R, Daemen J, Ding F, Tu S. Diagnostic Accuracy of Artificial Intelligence-Enhanced Ultrasonic Flow Ratio for On-Site Assessment of Coronary Stenosis. JACC Asia. 2026 May 11:S2772-3747(26)00268-1. doi: 10.1016/j.jacasi.2026.04.011. 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.
Fenghua Ding, MD, PhD principal investigator
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
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 Ruijin Hospital at 1 site in China.
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 4 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. 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 China. 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?
Yes. Results are posted in the registry (first posted 24 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Onsite UFR (time frame: baseline). 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 NCT05694065, 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 24 Jul 2026.