Skip to main content
OpenTrials
Completed

NCT Number: NCT07176585

A Prospective, Single-site, Single-group Value Study on the Diagnosis of Functional Myocardial Ischemia Based on IVUS Plaque Characteristics

This study aims to evaluate the accuracy of IVUS-calculated percent atheroma volume (PAV) for diagnosing functional myocardial ischemia, using FFR as the gold standard.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital,Cams & Pumc

Beijing, Beijing Municipality, 100037, China

About this study

This prospective, single-site, single-group target-value study aims to investigate the accuracy of intravascular ultrasound (IVUS)-based plaque characteristics in diagnosing functional myocardial ischemia, using coronary fractional flow reserve (FFR) as the gold standard.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Study participants must be at least 18 years of age and younger than 80 years of age, regardless of gender;
  • Stable coronary artery disease, unstable angina, or acute myocardial infarction (AMI ≥ 7 days);
  • Coronary angiography showed primary lesions with a visual stenosis of 30% to 90% in at least two coronary arteries ≥ 2.5 mm in diameter;
  • Willing to participate in the study and able to understand, read, and sign the informed consent form.

Exclusion criteria

  • STEMI as clinical presentation within 7 days;
  • Chronic Total Occlusion (CTO) as target vessel;
  • Significant contraindication to adenosine administration (e.g., atrioventricular block, severe asthma, etc.);
  • Study participants are currently participating in other drug or device clinical studies and have not achieved the study endpoints;
  • Pregnant or nursing;
  • Other situations considered by the investigator as unsuitable for participation in this study.

Treatment and study plan

Primary outcomes

  1. Accuracy of PAV calculated from IVUS images on diagnosing functional myocardial ischemia

    Time frame: Intraoperative period（After coronary angiography, before the potential PCI）

    Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy of PAV calculated from IVUS images on diagnosing functional myocardial ischemia PAV ≥ 39.0% is positive, PAV < 39.0% is negative).

  2. Sensitivity and specificity of PAV calculated from IVUS images on diagnosing functional myocardial ischemia

    Time frame: Intraoperative period（After coronary angiography, before the potential PCI）

    Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the sensitivity and specificity of PAV calculated from IVUS images on diagnosing functional myocardial ischemia (PAV ≥ 39.0% is positive, PAV < 39.0% is negative).

Secondary outcomes

  1. The positive predictive value, negative predictive value, Receiver Operating Characteristic Curve (ROC) and Area Under the Curve (AUC) of PAV calculated from IVUS images on the diagnosis of functional myocardial ischemia.

    Time frame: Intraoperative period（After coronary angiography, before the potential PCI）

    Using blood vessels as the research unit and FFR values measured by pressure microcatheters as reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the positive predictive value, negative predictive value, Receiver Operating Characteristic Curve (ROC), and Area Under the Curve (AUC) of PAV calculated from IVUS images on the diagnosis of functional myocardial ischemia (PAV ≥ 39.0% is positive, PAV < 39.0% is negative).

  2. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Total Atheroma Volume (TAV) calculated from IVUS images on the diagnosis of functional myocardial ischemia

    Time frame: Intraoperative period（After coronary angiography, before the potential PCI）

    Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Total Atheroma Volume (TAV) calculated from IVUS images on the diagnosis of functional myocardial ischemia.

  3. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Minimum Lumen Area (MLA) calculated from IVUS images on the diagnosis of functional myocardial ischemia

    Time frame: Intraoperative period（After coronary angiography, before the potential PCI）

    Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Minimum Lumen Area (MLA) calculated from IVUS images on the diagnosis of functional myocardial ischemia.

  4. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Plaque Burden (PB) calculated from IVUS images on the diagnosis of functional myocardial ischemia

    Time frame: Intraoperative period（After coronary angiography, before the potential PCI）

    Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Plaque Burden (PB) calculated from IVUS images on the diagnosis of functional myocardial ischemia.

  5. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Diameter Stenosis (DS%) calculated by Quantitative Coronary Angiography (QCA) on diagnosing functional myocardial ischemia

    Time frame: Intraoperative period（After coronary angiography, before the potential PCI）

    Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Diameter Stenosis degree (DS%) calculated by Quantitative Coronary Angiography (QCA) on diagnosing functional myocardial ischemia.

  6. Correlation between PAV, TAV, MLA, PB, DS% and FFR in pairwise comparisons

    Time frame: Intraoperative period（After coronary angiography, before the potential PCI）

    Using blood vessels as the research unit, conducting Passing Bablok regression analysis and Pearson linear correlation analysis on Percent Atheroma Volume (PAV), Total Atheroma Volume (TAV), Minimum Lumen Area (MLA), Plaque Burden (PB), Diameter Stenosis degree (DS%) and Fractional Flow Reserve (FFR).

  7. Correlation between PAV gradient calculated from IVUS images and FFR Pullback Pressure Gradient (PPG)

    Time frame: Intraoperative period（After coronary angiography, before the potential PCI）

    Using blood vessels as the research unit, PAV was calculated every 1mm along the vascular direction based on IVUS images, and FFR Pullback Pressure Gradient (PPG) distribution was calculated based on FFR pullback. The correlation between PAV gradient distribution along the vascular direction and FFR PPG was evaluated.

Sponsors and collaborators

Lead sponsor

Insight Lifetech Co., Ltd.

Industry

Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Jan 26, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.