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

NCT ID: NCT05694065

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-17
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Ischemic Heart Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

School of Biomedical Engineering, Shanghai Jiao Tong University

UNKNOWN

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fenghua Ding, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Locations

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20221110025331724

Identifier Type: -

Identifier Source: org_study_id