Functional ComprEhensive AssessmenT by IVUS Reconstruction in Patients With Suspected IschEmic Heart Disease (FEATURE)

N/AActive Not RecruitingNCT05694065

Ruijin Hospital112 enrolled

Overview

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.

1. Study overview This is a prospective, single-center, observational registry study of patients with suspected ischemic coronary artery disease. The purpose of this registry is to investigate the accuracy of online UFR assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived FFR as a reference standard. 2. Study population and sample size calculation are based on the diagnostic performance of previous studies, where an accuracy of 92% was found for UFR. Investigators conservatively estimate the diagnostic accuracy of online UFR assessment as 90% for consecutively enrolled patient population, and with a test target value set as 78% at a two-side significance level of 0.05, statistical power as 90%. Considering incomplete FFR/UFR data of 10% at most, a total of 112 patients need to be enrolled. 3. Participant enrollment was completed in November 2024; the study is currently in the follow-up phase with ongoing data collection and analysis.

Study Type

OBSERVATIONAL

Enrollment

112

Conditions

Ischemic Heart Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Diagnostic Accuracy of Onsite UFR

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.

Time frame: baseline

Secondary Outcomes

Sensitivity of Onsite UFR

The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Sensitivity was defined as the percentage of true positives correctly identified by UFR.

Time frame: baseline

Specificity of Onsite UFR

The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Specificity was defined as the percentage of true negatives correctly identified by UFR.

Time frame: baseline

Sensitivity of Minimal Lumen Area (MLA)

The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Sensitivity was defined as the percentage of true positives correctly identified by the prespecified MLA cutoff value.

Time frame: baseline

Specificity of MLA

The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Specificity was defined as the percentage of true negatives correctly identified by the prespecified MLA cutoff value.

Time frame: baseline

Data from ClinicalTrials.gov

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