Coronary Artery Disease (CAD)
Conditions
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.
Interventions
OTHERNot applicable- observational study
UFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine
Sponsors
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events (MACE) at 1 year | 1 year after the procedure | The primary outcome is MACE at 1 year, including cardiac death, any myocardial infarction and any ischaemia-driven revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events (MACE) at 1 month | 1 month after the procedure | MACE is defined as cardiac death, any myocardial infarction and any ischaemia-driven revascularization. |
| Major adverse cardiac events (MACE) at 6 months | 6 months after the procedure | MACE is defined as cardiac death, any myocardial infarction and any ischaemia-driven revascularization. |
Countries
China
Contacts
CONTACTJie Qian, MD
CONTACTCheng Yang, MD
Outcome results
None listed