Coronary Artery Disease (CAD)FUNCTION IIINCT06822894
Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease (CAD), run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This is a prospective, observational, single-center study. The main purpose of this study is to explore the predictive value of three coronary vessel-ultrasonic flow ratio (3V-UFR) for major adverse cardiovascular events (MACE) in patients with coronary artery disease within one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- Not applicable- observational study
- How many people
- 494 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2025to 31 Dec 2026
- How long will I take part?
- 1 Year
- 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: Patients aged 18 years or older admitted to Fuwai Hospital (Beijing, China) for coronary angiography and demonstrating angiographically confirmed ≥30% stenosis in all three major coronary arteries through visual assessment, will be consecutively enrolled in the study.
Who may be able to join
- Stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction
- Age ≥18 years
- Written informed consent
- Angiographically confirmed ≥30% diameter stenosis in all three major epicardial coronary arteries (left anterior descending, left circumflex, and right coronary artery)
- Patients with clinical indications for revascularization who have successfully completed percutaneous coronary intervention (PCI) prior to study enrollment
Who cannot join
- Ineligible for diagnostic IVUS examination
- Prior coronary artery bypass grafting (CABG)
- Myocardial infarction within 72 hours of coronary angiography
- Severe heart failure (NYHA grade ≥ III)
- Serum creatinine levels >150 umol/L, or glomerular filtration rates <45 ml/ kg/1.73 m2
- Allergy to the contrast agent or adenosine
Show all 10Show fewer
- Life expectancy < 2 years
- Severe coronary artery disease requiring CABG identified during angiography
- Extreme vascular tortuosity precluding IVUS catheter advancement
- Suboptimal IVUS image quality impairing quantitative analysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
About this study
This is a prospective, observational, single-center study. The main purpose of this study is to explore the predictive value of three coronary vessel-ultrasonic flow ratio (3V-UFR) for major adverse cardiovascular events (MACE) in patients with coronary artery disease within one year. The study will be conducted in Fuwai Hospital, and a total of at least 494 patients with all the three coronary vessel diameter stenoses ≥30% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS). IVUS imaging will be sent to an independent core laboratory for offline UFR calculation. Subsequently, a one-year follow-up was conducted on the patients. The primary endpoint was MACE within one year, which included cardiac death, any myocardial infarction, and ischemia-driven coronary revascularization. The association between the 3V-UFR (low 3V-UFR and high 3V-UFR grouped by median of 3V-UFR) and MACE is investigated, to determine its role in clinical prognosis for patient with coronary artery disease.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- Not applicable- observational study
- 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.
Not applicable- observational studyOther
UFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACE) at 1 year
The primary outcome is MACE at 1 year, including cardiac death, any myocardial infarction and any ischaemia-driven revascularization.
Measured: 1 year after the procedure
Secondary outcomes (2)
Major adverse cardiac events (MACE) at 1 month
MACE is defined as cardiac death, any myocardial infarction and any ischaemia-driven revascularization.
Measured: 1 month after the procedure
Major adverse cardiac events (MACE) at 6 months
MACE is defined as cardiac death, any myocardial infarction and any ischaemia-driven revascularization.
Measured: 6 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start18 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Prospective
- Enrolment
- 494 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822894
- Sponsor's protocol ID
- 2024-2-4034
- Acronym
- FUNCTION III
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06822894
- Acronym / sponsor ID
- FUNCTION III / 2024-2-4034
- Conditions
- Coronary Artery Disease (CAD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 494 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 2025 (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.
This is a prospective, observational, single-center study. The main purpose of this study is to explore the predictive value of three coronary vessel-ultrasonic flow ratio (3V-UFR) for major adverse cardiovascular events (MACE) in patients with coronary artery disease within one year. The study will be conducted in Fuwai Hospital, and a total of at least 494 patients with all the three coronary vessel diameter stenoses ≥30% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS). IVUS imaging will be sent to an independent core laboratory for offline UFR calculation. Subsequently, a one-year follow-up was conducted on the patients. The primary endpoint was MACE within one year, which included cardiac death, any myocardial infarction, and ischemia-driven coronary revascularization. The association between the 3V-UFR (low 3V-UFR and high 3V-UFR grouped by median of 3V-UFR) and MACE is investigated, to determine its role in clinical prognosis for patient with coronary artery disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older admitted to Fuwai Hospital (Beijing, China) for coronary angiography and demonstrating angiographically confirmed ≥30% stenosis in all three major coronary arteries through visual assessment, will be consecutively enrolled in the study.
Key inclusion criteria (5 listed)
- Stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction
- Age ≥18 years
- Written informed consent
- Angiographically confirmed ≥30% diameter stenosis in all three major epicardial coronary arteries (left anterior descending, left circumflex, and right coronary artery)
- Patients with clinical indications for revascularization who have successfully completed percutaneous coronary intervention (PCI) prior to study enrollment
Key exclusion criteria (10 listed)
- Ineligible for diagnostic IVUS examination
- Prior coronary artery bypass grafting (CABG)
- Myocardial infarction within 72 hours of coronary angiography
- Severe heart failure (NYHA grade ≥ III)
- Serum creatinine levels >150 umol/L, or glomerular filtration rates <45 ml/ kg/1.73 m2
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 |
|---|---|---|
| Not applicable- observational studyUFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine | Other | – |
Primary outcome
Major adverse cardiac events (MACE) at 1 year
Time frame: 1 year after the procedure
The primary outcome is MACE at 1 year, including cardiac death, any myocardial infarction and any ischaemia-driven revascularization.
2 secondary outcomes
Major adverse cardiac events (MACE) at 1 month
Time frame: 1 month after the procedure
Major adverse cardiac events (MACE) at 6 months
Time frame: 6 months after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 (CAD), run by China National Center for Cardiovascular Diseases 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 5 inclusion and 10 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 12 Feb 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?
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 Jie Qian, MD (+8613601396650, qianjfw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACE) at 1 year (time frame: 1 year after the procedure). 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 12 Feb 2026.