Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | NIRS-OCT examination |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| MACE events in the 24 months after operation | record the MACE events (cardiac death, myocardial infarction, progressive angina, revascularization) after operation in 24 months | 24 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| The maxLCBI4mm/FCTmin ratio | The maxLCBI4mm/FCTmin ratio is higher than 400/75 | 24 months after operation |
| The maxLCBI4mm/FCTmin ratio | The maxLCBI4mm/FCTmin ratio can be used as a continuous indicator |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months after operation |
| Correlation between maxLCBI4mm and MACE events |
Inclusion Criteria:
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:
1: Severe coagulation dysfunction (APTT greater than 3 times the upper limit of the normal range)
2: Severe hemodynamic disorder or shock that cannot be corrected
3: Patients with renal impairmentïĵeGFR<30 mL/min/1.73m2ïĵ
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
Not provided
Not provided
Not provided
Patients aged 18 years old or older ïĵwith diabetes requiring an OCT examination or treatment under OCT guidance
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenguang Li, Doctor | Contact | 13816767665 | li.chenguang@zs-hospital.sh.cn | |
| Rende Xu, Doctor | Contact | 86-15800624206 | xu.rende@zs-hospital.sh.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 24 months after operation |
| 24 months after operation |
| Correlation between the ratio of maxLCBI1mm to the thinnest fiber cap thickness with MACE events | 24 months after operation |
| 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 | 24 months after operation |
| Correlation between D-LCBI4mm lipid core load index and MACE events | 24 months after operation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided