Investigating the diagnostic accuracy of online Ultrasonic Flow Ratio (UFR) assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived fractional flow reserve (FFR) as a reference standard.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Subject must be ≥ 18 years
* Patients suspected with ischemic heart disease
* ≥ 1 diseased vessel with angiographic percent diameter stenosis between 40% and 80% in a vessel ≥ 2.5mm by visual estimation
* Target vessels are limited to major epicardial coronary arteries (left anterior descending artery \[LAD\], left circumflex artery \[LCX\], right coronary artery \[RCA\])
Exclusion Criteria:
* Patients with previous coronary artery bypass grafting (CABG)
* Myocardial infarction within 72h of coronary angiography
* Allergy to the contrast agent or adenosine
* Left main coronary artery stenosis ≥ 50%
* Target vessel with in-stent restenosis
* Target vessel with severe tortuosity or angulation
* 100% occlusion of target vessel
* Target vessel spasm or injury
* Target vessel with severe myocardial bridge
* Target vessel with severe thrombosis
* Intravascular ultrasound (IVUS) pullback fails to cover the complete target lesion
* Presence of false lumen at target vessel based on IVUS
* A serum creatinine level \>150 umol/l, or a glomerular filtration rate \< 45 ml/kg/1.73 m\^2
* Heart failure
* Ineligible for diagnostic intervention (IVUS or FFR examination)
Primary outcome measure(s)
Diagnostic Accuracy of Onsite UFR — baseline UFR was computed as the pressure ratio across a coronary stenosis, using FFR ≤0.80 as the reference standard for hemodynamically significant stenosis.
The diagnostic performance of onsite UFR was assessed by the area under the receiver operating characteristic (ROC) curve analysis, with diagnostic accuracy defined as the percentage of all correctly classified cases (true positives and true negatives) in the total population.
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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