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Active, Not Recruiting

NCT Number: NCT05694065

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

  • 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.
  • 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.
  • Participant enrollment was completed in November 2024; the study is currently in the follow-up phase with ongoing data collection and analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Diagnostic Accuracy of Onsite UFR

    Time frame: 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.

Secondary outcomes

  1. Sensitivity of Onsite UFR

    Time frame: baseline

    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.

  2. Specificity of Onsite UFR

    Time frame: baseline

    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.

  3. Sensitivity of Minimal Lumen Area (MLA)

    Time frame: baseline

    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.

  4. Specificity of MLA

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Erasmus Medical Center
  • School of Biomedical Engineering, Shanghai Jiao Tong University

Registry information

Official study title

Functional ComprEhensive AssessmenT by Intravascular UltrasoUnd Reconstruction in Patients With Suspected IschEmic Coronary Artery Disease (FEATURE)

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Jan 23, 2023
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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