A Prospective Multicenter Clinical Study： IntracOronary neaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary vulNerable Plaque in Patients With diabeTes

February 9, 2026 updated by: Shanghai Zhongshan Hospital

A Prospective Multicenter Clinical Study：IntracOnary neaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary vulNerable Plaque in Patients With diabeTes

To evaluate the correlation between maxLCBI4mm/FCTmin(a new index of lipid plaque based on NIRS-OCT technology) and fiber cap thickness , and the prognosis of patients, providing a new quantitative index for early, accurate and comprehensive identification of vulnerable plaques, and exploring preventive measures for adverse events such as cardiac death and recurrent myocardial infarction caused by vulnerable plaques, so as to improve the long-term prognosis of patients.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1516

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Zhongshan Hospital
        • Sub-Investigator:
          • Rende Xu, Doctor
        • Principal Investigator:
          • Junbo Ge, Doctor
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Chenguang Li, Doctor
        • Sub-Investigator:
          • Hongbo Yang, Doctor
        • Sub-Investigator:
          • Gang Zhao, Doctor
        • Sub-Investigator:
          • Yan Yan, Doctor
        • Sub-Investigator:
          • Hao Lu, Doctor
        • Sub-Investigator:
          • Kang Yao, Doctor
        • Sub-Investigator:
          • Jianying Ma, Doctor
        • Sub-Investigator:
          • Yizhe Wu, Doctor
        • Sub-Investigator:
          • Feng Zhang, Doctor
        • Sub-Investigator:
          • Shikun Xu, Doctor
        • Sub-Investigator:
          • Xin Zhong, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 years old or older ，with diabetes requiring an OCT examination or treatment under OCT guidance

Description

Inclusion Criteria:

  1. 18 years old or older, gender is not limited
  2. Patients with diabetes who require an OCT examination or treatment under OCT guidance (diabetes definition: active treatment with insulin or oral hypoglycemic agents at admission). For patients with diabetes who are treated with diet only, abnormal fasting blood sugar (>7 mmol/l), blood sugar >11.1 mmol/l at any time, or abnormal glucose tolerance tests based on World Health Organization standards need to be recorded.
  3. Be able to understand the purpose of clinical research, voluntarily participate can complete the observation as required and sign the informed consent form

5: Lesion stenosis greater than or equal to 50% without interventional treatment

6: The diameter of the blood vessel in the diseased segment is greater than or equal to 2.5 mm

Exclusion Criteria:

  • 1: Severe coagulation dysfunction (APTT greater than 3 times the upper limit of the normal range)

    2: Severe hemodynamic disorder or shock that cannot be corrected

    3: Patients with renal impairment（eGFR<30 mL/min/1.73m2）

    4: Severe symptoms of heart failure (NYHA III and above) or left ventricular ejection fraction <30%

    5: The presence or suspected presence of infective endocarditis or systemic active infection

    6: Patients with refractory ventricular arrhythmias who have previously undergone coronary bypass transplantation (CABG) or plan to undergo CABG during the study

    7: Patients with serious concurrent diseases such as advanced cancer have a life expectancy of less than 24 months

    8: Pregnant or lactating women, have a family plan within 24 months or are unwilling to take effective contraceptive measures

    9: The target vessel has severe calcification or severe tortuosity, which cannot be examined by OCT

    10: Have participated in other clinical trials or are participating in other drug/device clinical trials within 3 months prior to enrollment and have not met the primary endpoint

    11: Investigators believe that those who are unnecessary for OCT or not suitable for inclusion in this trial.

    12: There are multiple lesions in the same blood vessel, and the non-target lesion distance requiring treatment vascular segment is less than 5mm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Experimental group
NIRS-OCT examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE events in the 24 months after operation
Time Frame: 24 months after operation
record the MACE events (cardiac death, myocardial infarction, progressive angina, revascularization) after operation in 24 months
24 months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The maxLCBI4mm/FCTmin ratio
Time Frame: 24 months after operation
The maxLCBI4mm/FCTmin ratio is higher than 400/75
24 months after operation
The maxLCBI4mm/FCTmin ratio
Time Frame: 24 months after operation
The maxLCBI4mm/FCTmin ratio can be used as a continuous indicator
24 months after operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between maxLCBI1mm and MACE events
Time Frame: 24 months after operation
The association of maxLCBI1mm(the maximum lipid core load index in any 1mm long range as assessed by NIRS) with MACE events
24 months after operation
Correlation between maxLCBI4mm and MACE events
Time Frame: 24 months after operation
24 months after operation
Correlation between the ratio of maxLCBI1mm to the thinnest fiber cap thickness with MACE events
Time Frame: 24 months after operation
24 months after operation
Correlation between D-LCBI4mm lipid core load index and MACE events
Time Frame: 24 months after operation
24 months after operation
The newly defined vulnerable plaque 1) Presence of minimum lumen area <3.5 mm² 2) maxLCBI4mm / FCTmin higher than the median
Time Frame: 24 months after operation
The newly defined vulnerable plaque is more likely to be the primary culprit for MACE events than the traditionally defined vulnerable plaque
24 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2024

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORIENT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe