Clinical trial NCT06052670: Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Coronary Artery Lesions
Official title: Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of De Novo Coronary Artery Lesions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Stenosis
Keywords: intravascular ultrasound
ultrasonic flow ratio
fractional flow reserve
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-09-25
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the vessel level, using FFR as the reference standard
timeFrame: Immediately after the procedure
measure: Diagnostic accuracy of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard
timeFrame: Immediately after the procedure
measure: The AUC of UFR for coronary stenosis with FFR as the gold standard
timeFrame: Immediately after the procedure
Other outcomes:
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