NCT06822894 Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients With Coronary Artery Disease
| NCT ID | NCT06822894 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Coronary Artery Disease (CAD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 494 participants |
| Start Date | 2025-06-18 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 494 participants in total. It began in 2025-06-18 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06822894 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06822894 currently recruiting?
Yes, NCT06822894 is actively recruiting participants. Contact the research team at qianjfw@163.com for enrollment information.
Where is the NCT06822894 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06822894 clinical trial?
NCT06822894 is sponsored by China National Center for Cardiovascular Diseases. The trial plans to enroll 494 participants.