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

NCT06649305 | Recruiting DMC

• 1 other identifier: ORIENT
• Study Type: observational
• Target: 1,516
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Heart Disease (CHD); Diabetes (DM)

Keywords

near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• MACE events in the 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 Outcomes (2)

• The maxLCBI4mm/FCTmin ratio

  24 months after operation

• The maxLCBI4mm/FCTmin ratio

  24 months after operation

Other Outcomes (5)

• Correlation between maxLCBI1mm and MACE events

  24 months after operation

• Correlation between maxLCBI4mm and MACE events

  24 months after operation

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

  24 months after operation

Study Arms (1)

Experimental group

NIRS-OCT examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• : 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 renal impairment（eGFR\<30 mL/min/1.73m2）
• : Severe symptoms of heart failure (NYHA III and above) or left ventricular ejection fraction \<30%
• : The presence or suspected presence of infective endocarditis or systemic active infection
• : Patients with refractory ventricular arrhythmias who have previously undergone coronary bypass transplantation (CABG) or plan to undergo CABG during the study
• : Patients with serious concurrent diseases such as advanced cancer have a life expectancy of less than 24 months
• : Pregnant or lactating women, have a family plan within 24 months or are unwilling to take effective contraceptive measures
• : The target vessel has severe calcification or severe tortuosity, which cannot be examined by OCT
• : 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
• : There are multiple lesions in the same blood vessel, and the non-target lesion distance requiring treatment vascular segment is less than 5mm

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Chenguang Li, Doctor

CONTACT

13816767665; li.chenguang@zs-hospital.sh.cn

Rende Xu, Doctor

CONTACT

86-15800624206; xu.rende@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-01

Locations

CN (1)