Algorithm Validation for Fractional Flow Reserve Derived From Intravascular Ultrasound, Coronary Artery Disease, Coronary Stenosis
Conditions
Keywords
Intravascular Ultrasound, Fractional Flow Reserve, Computational Physiology, Algorithm Development
Brief summary
This is a retrospective, single-center study to develop and validate an updated algorithm for computing fractional flow reserve from intravascular ultrasound images (IvusFFR v2.0). The study will use existing intravascular ultrasound (IVUS) images and corresponding invasive fractional flow reserve (FFR) measurements obtained from approximately 100 patients who underwent clinically indicated coronary angiography, IVUS, and FFR assessment at Fuwai Hospital. All data will be anonymized prior to analysis. The primary objective is to assess the diagnostic accuracy of IvusFFR v2.0 in identifying hemodynamically significant coronary stenosis, using wire-based FFR ≤0.80 as the reference standard. This study involves no prospective intervention or additional patient contact.
Interventions
OTHERNo Intervention (Retrospective Data Analysis)
This is a retrospective observational study. No prospective intervention is administered. Participants' existing IVUS images and FFR measurements are analyzed.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * Underwent clinically indicated coronary angiography, intravascular ultrasound (IVUS) imaging, and invasive fractional flow reserve (FFR) measurement at Fuwai Hospital. * IVUS pullback imaging of sufficient quality for analysis, covering the entire lesion segment of interest. * Valid FFR measurement recorded. * Presence of at least one native coronary artery stenosis with visual diameter stenosis between 30% and 90%.
Exclusion criteria
* Chronic total occlusion (CTO) of the target vessel. * Prior coronary artery bypass grafting (CABG) involving the target vessel. * IVUS pullback did not cover the entire lesion. * Severe myocardial bridge or vessel spasm in the interrogated vessel. * Substantial thrombosis or dissection identified by IVUS. * Image quality deemed inadequate for analysis by two independent analysts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of IvusFFR v2.0 for Identifying Hemodynamically Significant Coronary Stenosis | Through study completion, an average of 6 months | Diagnostic accuracy of IvusFFR v2.0 in identifying hemodynamically significant coronary stenosis, using wire-based fractional flow reserve (FFR) ≤0.80 as the reference standard. Accuracy is defined as (True Positive + True Negative) / (Total Number of Vessels). |
Countries
China
Outcome results
None listed