Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Arter… (NCT06053944) | Clinical Trial Compass
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Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis
China120 participantsStarted 2023-10-18
Plain-language 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 (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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
Timeframe: Immediately after the procedure
2
Sensitivity and specificity of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
Timeframe: Immediately after the procedure
Trial details
NCT IDNCT06053944
SponsorChina National Center for Cardiovascular Diseases