Recruiting

Intracoronary NIRS-OCT Assessment of Vulnerable Plaque in Diabetic Patients

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Study Aim

This observational study aims to record Major Adverse Cardiac Events (MACE), such as cardiac death, myocardial infarction, progressive angina, and revascularization, within 24 months after the operation in diabetic patients with vulnerable plaque.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Cardiovascular Diseases+7

+ Coronary Disease

+ Diabetes Mellitus

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2024
See protocol details

Summary

Principal SponsorShanghai Zhongshan Hospital
Study ContactChenguang Li, DoctorMore contacts
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 30, 2024

Actual date on which the first participant was enrolled.

This study focuses on individuals with diabetes, aiming to identify vulnerable plaques in the coronary arteries using a new approach. The goal is to understand the correlation between a new index called maxLCBI4mm/FCTmin, which is based on Near-Infrared Spectroscopy and Optical Coherence Tomography (NIRS-OCT) technology, and the thickness of the fiber cap in the plaque. By doing so, the study hopes to provide a new quantitative index for the early, accurate, and comprehensive identification of vulnerable plaques. This could potentially lead to improved preventive measures for adverse events such as cardiac death and recurrent myocardial infarction, thereby enhancing the long-term prognosis for patients. In this observational study, participants will undergo the NIRS-OCT procedure to evaluate their coronary plaques. The study will then record any Major Adverse Cardiac Events (MACE) such as cardiac death, myocardial infarction, progressive angina, or revascularization that occur within 24 months after the procedure. This will help determine the correlation between the maxLCBI4mm/FCTmin index and the occurrence of these adverse events, potentially paving the way for improved care strategies for diabetic patients with coronary artery disease.

Official TitleA Prospective Multicenter Clinical Study：IntracOnary neaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary vulNerable Plaque in Patients With diabeTes
NCT06649305
Principal SponsorShanghai Zhongshan Hospital
Study ContactChenguang Li, DoctorMore contacts
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

1516 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesCoronary DiseaseDiabetes MellitusEndocrine System DiseasesHeart DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesMyocardial IschemiaGlucose Metabolism Disorders

Criteria

5 inclusion criteria required to participate
18 years old or older, gender is not limited
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.
Be able to understand the purpose of clinical research, voluntarily participate can complete the observation as required and sign the informed consent form
Lesion stenosis greater than or equal to 50% without interventional treatment
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12 exclusion criteria prevent from participating
Severe coagulation dysfunction (APTT greater than 3 times the upper limit of the normal range)
Severe hemodynamic disorder or shock that cannot be corrected
Patients with refractory ventricular arrhythmias who have previously undergone coronary bypass transplantation (CABG) or plan to undergo CABG during the study
The presence or suspected presence of infective endocarditis or systemic active infection
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Zhongshan Hospital

Shanghai, ChinaOpen Zhongshan Hospital in Google Maps
Recruiting
One Study Center