About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
1: Severe coagulation dysfunction (APTT greater than 3 times the upper limit of the normal range)
Trial population
Patients aged 18 years old or older ,with diabetes requiring an OCT examination or treatment under OCT guidance
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
MACE events in the 24 months after operation
record the MACE events (cardiac death, myocardial infarction, progressive angina, revascularization) after operation in 24 months
Secondary outcomes
The maxLCBI4mm/FCTmin ratio
The maxLCBI4mm/FCTmin ratio is higher than 400/75
The maxLCBI4mm/FCTmin ratio
The maxLCBI4mm/FCTmin ratio can be used as a continuous indicator
Other outcomes
Correlation between maxLCBI1mm and MACE events
The association of maxLCBI1mm(the maximum lipid core load index in any 1mm long range as assessed by NIRS) with MACE events
Correlation between maxLCBI4mm and MACE events
Correlation between the ratio of maxLCBI1mm to the thinnest fiber cap thickness with MACE events
The newly defined vulnerable plaque 1) Presence of minimum lumen area <3.5 mm² 2) maxLCBI4mm / FCTmin higher than the median
The newly defined vulnerable plaque is more likely to be the primary culprit for MACE events than the traditionally defined vulnerable plaque
Sponsors and contacts
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