Left Main Coronary Artery DiseaseFUNCTION IINCT06053944
Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis
An observational study of Left Main Coronary Artery Disease, 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 evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (UFR) in predicting functionally significant left main (LM) coronary stenosis with conventional pressure wire-based fractional flow reserve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Main Coronary Artery Disease
- What is being tested?
- fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2023to 31 Dec 2024
- How long will I take part?
- 5 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥ 18 years of age who will be admitted for coronary angiography and had an indication for FFR measurement at the Fuwai Hospital, Beijing, China, due to stable angina or unstable angina will be consecutively enrolled.
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
- Intermediated left main coronary lesions (diameter stenosis of 30%-80% by visual estimation from coronary angiography)
Who cannot join
- Ineligible for diagnostic IVUS or FFR examination
- Prior coronary artery bypass grafting of the interrogated vessels
- Myocardial infarction within 72 h of coronary angiography
- Severe heart failure
- Serum creatinine levels >150 umol/L, or glomerular filtration rates <45 ml/ kg/1.73 m2
- Allergy to the contrast agent or adenosine
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- Life expectancy < 2 years
- Proximal LAD diffuse lesions (diameter stenosis > 50%)
- IVUS pullback not covering the entire lesion
- Severe myocardial bridge in the interrogated vessel
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Select A State, 100037
Jie Qian, qianjfw@163.com
About this study
This is a prospective, observational, single-center study. The main purpose of this study is to evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (UFR) in predicting functionally significant left main (LM) coronary stenosis with conventional pressure wire-based fractional flow reserve (FFR) as the standard reference. The study will be conducted in Fuwai Hospital, and a total of 120 patients with intermediated left main coronary vessel diameter stenosis ≥30% and ≤80% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS) followed by FFR examination. IVUS imaging will be sent to an independent core laboratory for UFR calculation. UFR analyses were performed offline in a blinded fashion without awareness of FFR measurement. Using FFR≤0.80 as the gold standard, the sensitivity and specificity of UFR in the functional significance of left main coronary artery stenosis will be analyzed.
- Conditions
- Left Main Coronary Artery Disease
- Being tested
- fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)
- Keywords
- intravascular ultrasound, ultrasonic flow ratio, fractional flow reserve
- 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.
fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)Diagnostic test
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.
Diagnostic accuracy of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
Diagnostic accuracy is defined as UFFR (≤0.80 or >0.80) to identify hemodynamically-significant left main coronary stenosis with FFR (≤0.80 or >0.80) as the reference standard.
Measured: Immediately after the procedure
Sensitivity and specificity of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
Sensitivity is defined as the proportion of UFR ≤ 0.80 in vessels with hemodynamically-significant stenosis as measured by FFR (FFR ≤ 0.80); specificity is defined as the proportion of UFR > 0.80 in vessels without hemodynamically-significant stenosis as measured by FFR (FFR > 0.80).
Measured: Immediately after the procedure
Secondary outcomes (2)
Comparison of sensitivity and specificity of UFR and IVUS-derived minimal lumen area (MLA) in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
Sensitivity is defined as the proportion of UFR ≤ 0.80 in vessels with hemodynamically-significant stenosis as measured by FFR (FFR ≤ 0.80); specificity is defined as the proportion of UFR > 0.80 in vessels without hemodynamically-significant stenosis as measured by FFR (FFR > 0.80).
Measured: Immediately after the procedure
The AUC of UFR for left main coronary stenosis with FFR as the gold standard
AUC is defined as the area under the receiver-operating characteristic curve.
Measured: Immediately 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 posted26 Sep 2023
- Study start18 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Main Coronary Artery DiseaseStudies 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
- 120 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jie Qian, Principal investigator, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053944
- Sponsor's protocol ID
- 2022-12M-C&T-B-043
- Acronym
- FUNCTION II
- Status last verified
- Sep 2023
- First submitted
- 17 Sep 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis
- ClinicalTrials.gov ID
- NCT06053944
- Acronym / sponsor ID
- FUNCTION II / 2022-12M-C&T-B-043
- Conditions
- Left Main Coronary Artery Disease
- Keywords
- intravascular ultrasound, ultrasonic flow ratio, fractional flow reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Sep 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.
This is a prospective, observational, single-center study. The main purpose of this study is to evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (UFR) in predicting functionally significant left main (LM) coronary stenosis with conventional pressure wire-based fractional flow reserve (FFR) as the standard reference. The study will be conducted in Fuwai Hospital, and a total of 120 patients with intermediated left main coronary vessel diameter stenosis ≥30% and ≤80% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS) followed by FFR examination. IVUS imaging will be sent to an independent core laboratory for UFR calculation. UFR analyses were performed offline in a blinded fashion without awareness of FFR measurement. Using FFR≤0.80 as the gold standard, the sensitivity and specificity of UFR in the functional significance of left main coronary artery stenosis will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 18 years of age who will be admitted for coronary angiography and had an indication for FFR measurement at the Fuwai Hospital, Beijing, China, due to stable angina or unstable angina will be consecutively enrolled.
Key inclusion criteria (4 listed)
- Stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction
- Age ≥18 years
- Written informed consent
- Intermediated left main coronary lesions (diameter stenosis of 30%-80% by visual estimation from coronary angiography)
Key exclusion criteria (10 listed)
- Ineligible for diagnostic IVUS or FFR examination
- Prior coronary artery bypass grafting of the interrogated vessels
- Myocardial infarction within 72 h of coronary angiography
- Severe heart failure
- 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 |
|---|---|---|
| fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)UFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine. | Diagnostic test | – |
Primary outcome
Diagnostic accuracy of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
Time frame: Immediately after the procedure
Diagnostic accuracy is defined as UFFR (≤0.80 or >0.80) to identify hemodynamically-significant left main coronary stenosis with FFR (≤0.80 or >0.80) as the reference standard.
Sensitivity and specificity of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
Time frame: Immediately after the procedure
Sensitivity is defined as the proportion of UFR ≤ 0.80 in vessels with hemodynamically-significant stenosis as measured by FFR (FFR ≤ 0.80); specificity is defined as the proportion of UFR > 0.80 in vessels without hemodynamically-significant stenosis as measured by FFR (FFR > 0.80).
2 secondary outcomes
Comparison of sensitivity and specificity of UFR and IVUS-derived minimal lumen area (MLA) in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
Time frame: Immediately after the procedure
The AUC of UFR for left main coronary stenosis with FFR as the gold standard
Time frame: Immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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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.
Jie Qian principal investigator
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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 Left Main Coronary Artery Disease, 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 4 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: status not confirmed, as of the sponsor's last update on 22 Jan 2024. 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?
Results are not available in the source record.
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?
Diagnostic accuracy of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard (time frame: Immediately after the procedure). 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 22 Jan 2024.