Actively Recruiting
Intracoronary Near-Infrared Spectroscopy and Optical Coherence Tomography to Evaluate Coronary Vulnerable Plaque in Patients with Diabetes: A Prospective Multicenter Clinical Study
Led by Shanghai Zhongshan Hospital · Updated on 2026-02-12
1516
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the relationship between a new index called maxLCBI4mm/FCTmin, based on NIRS-OCT technology, and the thickness of the fiber cap in coronary plaques in patients with diabetes. The goal is to identify vulnerable plaques early and accurately, and to explore ways to prevent serious heart events like cardiac death and recurrent heart attacks, ultimately aiming to improve long-term patient outcomes. Participants will undergo an NIRS-OCT examination to assess their coronary plaques. This observational study focuses on patients with diabetes who need an OCT examination or treatment guided by OCT. The study does not involve drug treatments but carefully monitors the plaques using advanced imaging technology. During the study, participants will be followed for 24 months after their procedure to track major adverse cardiac events (MACE). Researchers will measure the maxLCBI4mm/FCTmin ratio and monitor heart health outcomes. The study requires participants to provide informed consent and be available for follow-up assessments over the two-year period.
CONDITIONS
Brief 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 OCT examination or treatment under OCT guidance
- Able to understand the study purpose, willing to participate, and sign informed consent
- Lesion stenosis of 50% or greater without prior interventional treatment
- Diameter of the diseased blood vessel segment is 2.5 mm or larger
You will not qualify if you...
- Severe coagulation dysfunction (APTT > 3 times normal upper 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, prior or planned coronary bypass grafting
- Advanced cancer or serious diseases with life expectancy under 24 months
- Pregnant or breastfeeding women, or planning pregnancy within 24 months without effective contraception
- Target vessel with severe calcification or tortuosity preventing OCT examination
- Participation in other drug/device clinical trials within 3 months without reaching primary endpoint
- Multiple lesions in the same vessel with less than 5mm between non-target and target lesions
- Investigator judgment that OCT is unnecessary or the patient is unsuitable for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of the procedure
Participants undergo intracoronary near-infrared spectroscopy and optical coherence tomography to evaluate coronary vulnerable plaque.
1 visit (in-person)
Duration - 24 months
Participants are monitored for major adverse cardiovascular events (MACE) and plaque characteristics for 24 months after the procedure.
Follow-up visits as scheduled over 24 months
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
C
Chenguang Li, Doctor
R
Rende Xu, Doctor
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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