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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhongshan Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Chenguang Li, Doctor
• Email: li.chenguang@zs-hospital.sh.cn
• Phone: 13816767665

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.