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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,516 Participants
are grouped into 1 trial group
Group A: Experimental group

Trial outcomes

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

Time frame
24 months after operation

Secondary outcomes

1

The maxLCBI4mm/FCTmin ratio

The maxLCBI4mm/FCTmin ratio is higher than 400/75

Time frame
24 months after operation
2

The maxLCBI4mm/FCTmin ratio

The maxLCBI4mm/FCTmin ratio can be used as a continuous indicator

Time frame
24 months after operation

Other outcomes

1

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

Time frame
24 months after operation
2

Correlation between maxLCBI4mm and MACE events

Time frame
24 months after operation
3

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

Time frame
24 months after operation
4

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

Time frame
24 months after operation

Sponsors and contacts

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