Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2026-01-02 @ 11:35 AM
Study NCT ID:
NCT05512832
Status:
COMPLETED
Last Update Posted:
2022-08-23
First Post:
2022-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In-stent Restenosis and Pericoronary Fat Attenuation Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-21', 'studyFirstSubmitDate': '2022-08-17', 'studyFirstSubmitQcDate': '2022-08-21', 'lastUpdatePostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat attenuation index (FAI)', 'timeFrame': '2022.8.15-2023.8.14', 'description': 'The pericoronary FAI was defined as the mean CT attenuation of the pericoronary adipose tissue (-190 to -30 HU). Peri-stent FAI was measured around the stent segment of all 3 major epicardial coronary vessels.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pericoronary fat attenuation index'], 'conditions': ['In-stent Restenosis']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the predictive value of fat attenuation index (FAI) and related radiomics characteristics of pericoronary fat in patients after percutaneous coronary intervention (PCI) for the occurrence of in-stent restenosis (ISR) during the follow-up period (9 to 24 months). The results of this study are expected to provide an early assessment of the inflammation around the coronary lesion segment in patients after PCI, and provide a basis for early targeted intensive drug therapy in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary heart disease who have undergone PCI and followed up angiography 9 to 24 months after PCI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with coronary heart disease who have undergone PCI;\n* Patients followed up coronary angiography 9 to 24 months after PCI;\n* Patients received chest CT examination during inpatient/outpatient follow-up;\n\nExclusion Criteria:\n\n* Patients with diseases of the immune system;\n* Patients with history of tumor diseases;\n* Patients with chronic/acute infectious diseases;\n* Image quality is not sufficient for analysis;'}, 'identificationModule': {'nctId': 'NCT05512832', 'briefTitle': 'In-stent Restenosis and Pericoronary Fat Attenuation Index', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Construction and Evaluation of Clinical Prediction Model of In-stent Restenosis After Percutaneous Coronary Intervention by Pericoronary Fat Attenuation Index and Radiomics Characteristics', 'orgStudyIdInfo': {'id': 'EARLY-ISR FAI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ISR', 'description': 'Patient developed in-stent restenosis 9-24 months after stenting'}, {'label': 'no ISR', 'description': 'Patients were free of in-stent restenosis 9-24 months after stenting'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Song Ding', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}