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NCT Number: NCT06649305

A Prospective Multicenter Clinical Study: IntracOronary 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Chenguang Li, Doctor

CONTACT

[email protected]

86-13816767665

Chenguang Li, Doctor

SUB_INVESTIGATOR

Feng Zhang, Doctor

SUB_INVESTIGATOR

Gang Zhao, Doctor

SUB_INVESTIGATOR

Hao Lu, Doctor

SUB_INVESTIGATOR

Hongbo Yang, Doctor

SUB_INVESTIGATOR

Jianying Ma, Doctor

SUB_INVESTIGATOR

Junbo Ge, Doctor

PRINCIPAL_INVESTIGATOR

Kang Yao, Doctor

SUB_INVESTIGATOR

Rende Xu, Doctor

CONTACT

[email protected]

86-15800624206

Rende Xu, Doctor

SUB_INVESTIGATOR

Shikun Xu, Doctor

SUB_INVESTIGATOR

Xin Zhong, Doctor

SUB_INVESTIGATOR

Yan Yan, Doctor

SUB_INVESTIGATOR

Yizhe Wu, Doctor

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. The maxLCBI4mm/FCTmin ratio

    Time frame: 24 months after operation

    The maxLCBI4mm/FCTmin ratio is higher than 400/75

  2. The maxLCBI4mm/FCTmin ratio

    Time frame: 24 months after operation

    The maxLCBI4mm/FCTmin ratio can be used as a continuous indicator

Other outcomes

  1. 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

  2. Correlation between maxLCBI4mm and MACE events

    Time frame: 24 months after operation

  3. Correlation between the ratio of maxLCBI1mm to the thinnest fiber cap thickness with MACE events

    Time frame: 24 months after operation

  4. 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

  5. Correlation between D-LCBI4mm lipid core load index and MACE events

    Time frame: 24 months after operation

Study contacts

Contact information is provided by the study sponsor or research team.

Chenguang Li, Doctor

CONTACT

[email protected]

13816767665

Rende Xu, Doctor

CONTACT

[email protected]

86-15800624206

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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