NIRS-OCT imaging to find vulnerable coronary plaques in people with diabetes

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

This project will test whether a new combined NIRS-OCT index (maxLCBI4mm/FCTmin) can identify vulnerable coronary plaques in adults with diabetes who are undergoing coronary OCT.

Quick facts

• Study type: Observational
• Enrollment: 1516 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06649305 on ClinicalTrials.gov

What this trial studies

This is a prospective observational imaging study using intracoronary near-infrared spectroscopy (NIRS) combined with optical coherence tomography (OCT) to measure lipid burden (maxLCBI4mm) and fibrous cap thickness (FCT) in coronary lesions. Adult patients with diabetes who require OCT and have lesions ≥50% and vessel diameter ≥2.5 mm will undergo NIRS-OCT imaging. The study will correlate the combined index maxLCBI4mm/FCTmin with cap thickness and follow patients for clinical outcomes such as recurrent myocardial infarction and cardiac death. The aim is to create a quantitative marker to better identify vulnerable plaques and explore its relationship to adverse events over time.

Who should consider this trial

Good fit: Adults with diabetes who are scheduled for intracoronary OCT, have a coronary lesion with ≥50% stenosis and a vessel diameter ≥2.5 mm, and can provide informed consent are ideal candidates.

Not a fit: People without diabetes, those whose target lesion is already treated with intervention, or patients with severe coagulation dysfunction or hemodynamic instability are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could give clinicians a quantitative imaging marker to detect high-risk plaques earlier and help guide prevention to reduce heart attacks and cardiac deaths in people with diabetes.

How similar studies have performed: Previous studies using NIRS and OCT separately have shown they can detect lipid-rich and thin-cap plaques, but the specific combined index maxLCBI4mm/FCTmin is relatively novel and not yet widely validated for outcome prediction.

Eligibility criteria

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

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Chenguang Li, Doctor

Conditions Coronary Heart Disease; Diabetes; near-infrared spectroscopy