Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-01-01 @ 5:55 AM
Study NCT ID:
NCT06649305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-18
First Post:
2024-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Multicenter Clinical Study： IntracOnary NeaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary VulNerable Plaque in Patients with DiabeTes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1516}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2024-10-17', 'studyFirstSubmitQcDate': '2024-10-17', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation between maxLCBI1mm and MACE events', 'timeFrame': '24 months after operation', 'description': 'The association of maxLCBI1mm(the maximum lipid core load index in any 1mm long range as assessed by NIRS) with MACE events'}, {'measure': 'Correlation between maxLCBI4mm and MACE events', 'timeFrame': '24 months after operation'}, {'measure': 'Correlation between the ratio of maxLCBI1mm to the thinnest fiber cap thickness with MACE events', 'timeFrame': '24 months after operation'}, {'measure': 'The newly defined vulnerable plaque is more likely to be the primary culprit for MACE events than the traditionally defined vulnerable plaque', 'timeFrame': '24 months after operation'}, {'measure': 'Correlation between D-LCBI4mm lipid core load index and MACE events', 'timeFrame': '24 months after operation'}], 'primaryOutcomes': [{'measure': 'MACE events in the 24 months after operation', 'timeFrame': '24 months after operation', 'description': 'record the MACE events (cardiac death, myocardial infarction, progressive angina, revascularization) after operation in 24 months'}], 'secondaryOutcomes': [{'measure': 'The maxLCBI4mm/FCTmin ratio', 'timeFrame': '24 months after operation', 'description': 'The maxLCBI4mm/FCTmin ratio is higher than 400/75'}, {'measure': 'The maxLCBI4mm/FCTmin ratio', 'timeFrame': '24 months after operation', 'description': 'The maxLCBI4mm/FCTmin ratio can be used as a continuous indicator'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relationship Between Target Vascular Lipid Content and Long Term Prognosis in Diabetic Patients with Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18-80 years ，with diabetes requiring interventional therapy, non-target lesions greater than 50% stenosis, at least 2 coronary arteries (including suspected criminal coronary arteries) suitable for NIRS-OCT imaging, requiring endovascular imaging or requiring endovascular image-guided interventional therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1: Aged 18-80 years, gender is not limited\n\n 2: Patients with diabetes who require interventional therapy (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.\n\n 3: Endoscopic imaging examination or interventional therapy under the guidance of endoscopic imaging is required\n\n 4: Be able to understand the purpose of clinical research, voluntarily participate can complete the observation as required and sign the informed consent form\n\n 5: At least 2 coronary arteries (including suspected criminal coronary arteries) are suitable for NIRS-OCT imaging\n\n 6: Stenosis with non-target lesions \\> 50%\n\nExclusion Criteria:\n\n* 1: Severe coagulation dysfunction (APTT greater than 3 times the upper limit of the normal range)\n\n 2: Severe hemodynamic disorder or shock that cannot be corrected\n\n 3: Patients with renal impairment（eGFR\\<30 mL/min/1.73m2）\n\n 4: Severe symptoms of heart failure (NYHA III and above) or left ventricular ejection fraction \\<30%\n\n 5: The presence or suspected presence of infective endocarditis or systemic active infection\n\n 6: Patients with refractory ventricular arrhythmias who have previously undergone coronary bypass transplantation (CABG) or plan to undergo CABG during the study\n\n 7: Patients with serious concurrent diseases such as advanced cancer have a life expectancy of less than 24 months\n\n 8: Pregnant or lactating women, have a family plan within 24 months or are unwilling to take effective contraceptive measures\n\n 9: The target vessel has severe calcification or severe tortuosity, which cannot be examined by OCT\n\n 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\n\n 11: Investigators believe that those who are unnecessary for OCT or not suitable for inclusion in this trial.\n\n 12: There are multiple lesions in the same blood vessel, and the non-target lesion distance requiring treatment vascular segment is less than 5mm'}, 'identificationModule': {'nctId': 'NCT06649305', 'briefTitle': 'A Prospective Multicenter Clinical Study： IntracOnary NeaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary VulNerable Plaque in Patients with DiabeTes', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'A Prospective Multicenter Clinical Study：IntracOnary NeaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary VulNerable Plaque in Patients with DiabeTes', 'orgStudyIdInfo': {'id': 'ORIENT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group', 'description': 'NIRS-OCT examination'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhongshan Hospital Fudan University', 'role': 'CONTACT', 'email': 'li.chenguang@zs-hospital.sh.cn', 'phone': '13816767665'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}