Actively Recruiting
A Prospective Multicenter Clinical Study： IntracOronary neaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary vulNerable Plaque in Patients With diabeTes
Led by Shanghai Zhongshan Hospital · Updated on 2026-02-12
1516
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Prospective Multicenter Clinical Study： IntracOronary neaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary vulNerable Plaque in Patients With diabeTes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older, any gender
- Diagnosed with diabetes requiring insulin or oral medication treatment at admission, or abnormal blood sugar levels as defined by WHO for those treated with diet only
- Able to understand the study purpose, willing to participate and complete the observation, and sign informed consent
- Lesion stenosis of 50% or greater without interventional treatment
- Diameter of the diseased blood vessel segment 2.5 mm or larger
You will not qualify if you...
- Severe coagulation dysfunction with APTT more than 3 times the upper normal limit
- Severe hemodynamic disorder or uncorrectable shock
- Renal impairment with eGFR less than 30 mL/min/1.73m2
- Severe heart failure symptoms (NYHA III or above) or left ventricular ejection fraction below 30%
- Presence or suspicion of infective endocarditis or active systemic infection
- Refractory ventricular arrhythmias or prior/planned coronary bypass surgery
- Advanced cancer or serious diseases with life expectancy under 24 months
- Pregnant or lactating women, planning family within 24 months, or unwilling to use contraception
- Target vessel with severe calcification or tortuosity unsuitable for OCT
- Participation in other drug/device trials within 3 months without meeting primary endpoint
- Investigator judgment deeming OCT unnecessary or patient unsuitable
- Multiple lesions in the same vessel with less than 5 mm between target and non-target lesions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
C
Chenguang Li, Doctor
CONTACT
R
Rende Xu, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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