Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT05623527
Status:
COMPLETED
Last Update Posted:
2024-08-02
First Post:
2022-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Characteristics and Prognosis of Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13324}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-11-13', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of acute cerebrovascular disease', 'timeFrame': 'About 4 weeks after the enrollment', 'description': 'Number and rate of patients with acute cerebrovascular disease secondary to patients receiving cardiac electronic implants. The data were obtained from the medical records.'}], 'secondaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': 'About 4 weeks after the enrollment', 'description': 'In-hospital mortality of acute cerebrovascular disease in patients receiving cardiac electronic implants. The data were obtained from the medical records.'}, {'measure': 'All-cause mortality', 'timeFrame': '3 months after the enrollment', 'description': 'All-cause mortality within 3 months of telephone follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Atrial Fibrillation', 'Pacemaker']}, 'descriptionModule': {'briefSummary': "To investigate the incidence, clinical characteristics and prognosis of acute ischemic and hemorrhagic cerebrovascular disease secondary to the implantation of cardiovascular implantable electronic devices, so as to provide a basis for subsequent treatment strategies and risk factor stratification.\n\nThis study intends to retrospectively collect the incidence and case characteristics of acute cerebral infarction, cerebral embolism, transient ischemic attack and cerebral hemorrhage in CIED patients admitted to the First Affiliated Hospital of Xi 'an Jiaotong University and other centers from January 2012 to September 2022. Then, the incidence of poor prognosis and related factors of patients within 3 months were followed up by telephone to provide a basis for subsequent treatment strategy and risk factor stratification."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'From January 2012 to September 2022, any patients with cardiac implantable electronic device', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of acute cerebrovascular disease secondary to cardiac electronic device implantation.\n* Hospitalized from January 2012 to September 2022.\n\nExclusion Criteria:\n\n* Patients were absent of cranial CT/MRI scan data.\n* Patients refuse to take follow-up interviews.'}, 'identificationModule': {'nctId': 'NCT05623527', 'acronym': 'SOS-CARE', 'briefTitle': 'Clinical Characteristics and Prognosis of Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Clinical Characteristics and Prognosis of Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants (SOS-CARE) - A Multicenter Real-world Trial', 'orgStudyIdInfo': {'id': 'XJTU1AF2022LSK-408'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ischemic stroke group', 'description': '1. Ischemic stroke secondary to patients receiving cardiac electronic implants\n2. Ischemic stroke met the diagnostic criteria of the 2018 edition of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke, and was confirmed by cranial CT/MRI scan.', 'interventionNames': ['Device: cardiac electronic implants']}, {'label': 'Transient ischemic attack group', 'description': '1. Transient ischemic attack secondary to patients receiving cardiac electronic implants\n2. Ischemic stroke met the diagnostic criteria of the 2018 edition of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke, and was confirmed negative of new onset of infarction by cranial CT/MRI scan.', 'interventionNames': ['Device: cardiac electronic implants']}, {'label': 'Cerebral hemorrhage group', 'description': '1. Cerebral hemorrhage secondary to patients receiving cardiac electronic implants\n2. Cerebral hemorrhage met the diagnostic criteria of the 2021 Chinese Guidelines for the Diagnosis and Treatment of cerebral hemorrhage and was confirmed by head CT/MRI.', 'interventionNames': ['Device: cardiac electronic implants']}], 'interventions': [{'name': 'cardiac electronic implants', 'type': 'DEVICE', 'description': 'Cardiac electronic implants(CIED) includes permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), three-chamber pacemaker for cardiac resynchronization therapy defibrillator, lead free pacemaker, etc.', 'armGroupLabels': ['Cerebral hemorrhage group', 'Ischemic stroke group', 'Transient ischemic attack group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710041', 'city': "Xi'an", 'state': 'Shannxi Province', 'country': 'China', 'facility': 'Guoliang Li', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Guoliang Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Xi'an Jiaotong University First Affiliated Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}