A Prospective Multicenter Clinical Study： IntracOronary neaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary vulNerable Plaque in Patients With diabeTes
NCT ID: NCT06649305
Last Updated: 2026-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1516 participants
OBSERVATIONAL
2024-10-30
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Experimental group
NIRS-OCT examination
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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
Exclusion Criteria
2: Severe hemodynamic disorder or shock that cannot be corrected
3: Patients with renal impairment（eGFR\<30 mL/min/1.73m2）
4: Severe symptoms of heart failure (NYHA III and above) or left ventricular ejection fraction \<30%
5: The presence or suspected presence of infective endocarditis or systemic active infection
6: Patients with refractory ventricular arrhythmias who have previously undergone coronary bypass transplantation (CABG) or plan to undergo CABG during the study
7: Patients with serious concurrent diseases such as advanced cancer have a life expectancy of less than 24 months
8: Pregnant or lactating women, have a family plan within 24 months or are unwilling to take effective contraceptive measures
9: The target vessel has severe calcification or severe tortuosity, which cannot be examined by OCT
10: Have participated in other clinical trials or are participating in other drug/device clinical trials within 3 months prior to enrollment and have not met the primary endpoint
11: Investigators believe that those who are unnecessary for OCT or not suitable for inclusion in this trial.
12: There are multiple lesions in the same blood vessel, and the non-target lesion distance requiring treatment vascular segment is less than 5mm
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Locations
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Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ORIENT
Identifier Type: -
Identifier Source: org_study_id
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