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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Zhongshan Hospital
RECRUITING
Shanghai
Contact Information
Primary
Chenguang Li, Doctor
li.chenguang@zs-hospital.sh.cn
13816767665
Backup
Rende Xu, Doctor
xu.rende@zs-hospital.sh.cn
86-15800624206
Time Frame
Start Date: 2024-10-30
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 1516
Treatments
Experimental group
NIRS-OCT examination
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov