Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT07080151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-30
First Post:
2025-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zhongshan Hospital Cardiovascular Imaging Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2045-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-27', 'studyFirstSubmitDate': '2025-07-14', 'studyFirstSubmitQcDate': '2025-07-14', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': '10 years', 'description': 'Major adverse cardiac events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Computed Tomography Angiography', 'Coronary Angiography', 'Intravascular Ultrasound', 'Optical Coherence Tomography', 'Cardiac Magnetic Resonance Imaging'], 'conditions': ['Atherosclerosis', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this registry is to establish a multi-modality cardiac image database including coronary angiography (CAG), optical coherence tomography (OCT), intravascular ultrasound (IVUS), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) for future studies. The main goal of this collaboration is to create a resource for advanced research on atherosclerosis through image analysis.', 'detailedDescription': 'This registry plans to establish a multi-modality cardiac image database including coronary angiography (CAG), optical coherence tomography (OCT), intravascular ultrasound (IVUS), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) for future studies. Patients who underwent CAG or CTA during Aug 1st, 2025 and Dec 31st, 2035 at Zhongshan Hospital will be included in this registry. In addition, patients with CTA or at least one of OCT/IVUS/CMR between Jan 1st, 2012 and Jul 31st, 2025 will be retrospectively registered. Subgroups of these patients will have OCT/IVUS/CMR as according to their clinical presentations and requests from their doctors in charge. This registry aims to create a resource for advanced imaging research on atherosclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with potential cardiovascular disease(s) (CVD) or diagnosed with CVD who were referred to CTA and/or CAG at Zhongshan Hospital, Fudan university.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with potential cardiovascular disease(s) (CVD) or diagnosed with CVD who were referred to CTA and/or CAG.\n* Optional cardiac imagings, namely OCT/IVUS/CMR were up to doctors in charge and not mandatory.\n\nExclusion Criteria:\n\n* Patient without any of the above mentioned cardiac imaging record.'}, 'identificationModule': {'nctId': 'NCT07080151', 'briefTitle': 'Zhongshan Hospital Cardiovascular Imaging Registry', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Zhongshan Hospital Cardiovascular Imaging Registry', 'orgStudyIdInfo': {'id': 'ZSCD2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study cohort', 'description': 'Patients who underwent CAG or CTA during Aug 1st, 2025 and Dec 31st, 2035 at Zhongshan Hospital will be included in this registry. In addition, patients with CTA or at least one of OCT/IVUS/CMR between Jan 1st, 2012 and Jul 31st, 2025 will be retrospectively registered.', 'interventionNames': ['Other: Cardiac imaging']}], 'interventions': [{'name': 'Cardiac imaging', 'type': 'OTHER', 'otherNames': ['CAG/CTA/OCT/IVUS/CMR'], 'description': 'Patients who underwent CTA or CAG, with or without other cardiac imaging modelities (OCT, IVUS, or CMR) will be enrolled in this registry.', 'armGroupLabels': ['Study cohort']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chenguang Li, MD, PhD', 'role': 'CONTACT', 'email': 'li.chenguang@zs-hospital.sh.cn', 'phone': '8602164041990'}], 'overallOfficials': [{'name': 'Junbo Ge, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Department, Zhongshan Hospital, Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD for this observational study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Cardiology', 'investigatorFullName': 'Junbo Ge', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}