Coronary Artery Stenosis
Conditions
Keywords
intravascular ultrasound, ultrasonic flow ratio, fractional flow reserve
Brief summary
This is a prospective, single-center study. The primary purpose of this study is to evaluate the sensitivity and specificity of offline computational ultrasonic flow ratio (UFR) 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 408 patients with 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 coronary artery stenosis will be analyzed.
Interventions
DIAGNOSTIC_TESTfractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)
pressure wire-based fractional flow reserve (FFR); intravascular ultrasound (IVUS)-based ultrasonic flow ratio (UFR)
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 * Intermediated 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 * IVUS pullback not covering the entire lesion * Severe myocardial bridge in the interrogated vessel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard | Immediately after the procedure | Sensitivity is defined as the proportion of UFR ≤ 0.80 in patients with hemodynamically-significant stenosis as measured by FFR (FFR ≤ 0.80); specificity is defined as the proportion of UFR \> 0.80 in patients without hemodynamically-significant stenosis as measured by FFR (FFR \> 0.80). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The AUC of UFR for coronary stenosis with FFR as the gold standard | Immediately after the procedure | AUC is defined as the area under the receiver-operating characteristic curve |
| Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the vessel level, using FFR as the reference standard | 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 \> 0.8). |
| Diagnostic accuracy of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard | Immediately after the procedure | Diagnostic accuracy is defined as UFFR (≤0.80 or \>0.80) to identify hemodynamically-significant coronary stenosis with FFR (≤0.8 or \>0.8) as the reference standard. |
Contacts
Primary ContactJie Qian, MD
Backup ContactCheng Yang, MD
Outcome results
None listed