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

NCT07176585 | Completed

• 1 other identifier: CIP-0201
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

IVUS; FFR; PCI; CAD

Outcome Measures

Primary Outcomes (2)

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

  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).

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

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

  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).

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

Secondary Outcomes (7)

• 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.

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

• 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

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

• 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

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

• 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

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

• 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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with multivessel coronary artery disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insight Lifetech Co., Ltd.: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (1)

Fuwai Hospital,Cams & Pumc

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 16, 2025
• Study Start: September 23, 2025
• Primary Completion: January 4, 2026
• Study Completion: January 4, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

CN (1)