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

NCT05694065 | Active Not Recruiting Results

• 1 other identifier: 20221110025331724
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline

Secondary Outcomes (4)

• Sensitivity of Onsite UFR

  baseline

• Specificity of Onsite UFR

  baseline

• Sensitivity of Minimal Lumen Area (MLA)

  baseline

• Specificity of MLA

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with suspected ischemic heart disease who undergo coronary angiography.

You may qualify if:

• 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 \[RCA\])

You may not qualify if:

• 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
• % 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)

Sponsors & Collaborators

• Ruijin Hospital: lead
• School of Biomedical Engineering, Shanghai Jiao Tong University: collaborator
• Erasmus Medical Center: collaborator

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Fenghua Ding
• Organization: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

ruijindfh@126.com

+00 86 21 64370045

Study Officials

• Fenghua Ding, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: February 17, 2023
• Primary Completion: November 22, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-08

Locations

CN (1)