Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT05475860
Status:
UNKNOWN
Last Update Posted:
2022-07-27
First Post:
2022-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers Predicting Atrial High Rate Episodes in Cardiac Implantable Electronic Device Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017147', 'term': 'Defibrillators, Implantable'}, {'id': 'D058406', 'term': 'Cardiac Resynchronization Therapy'}], 'ancestors': [{'id': 'D047548', 'term': 'Defibrillators'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D002304', 'term': 'Cardiac Pacing, Artificial'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'biomarkers including soluble ST-2 and FGF-23, single nucleotide polymorphism'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-24', 'studyFirstSubmitDate': '2022-07-24', 'studyFirstSubmitQcDate': '2022-07-24', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurrence of atrial high rate episode', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Factors predicting the occurrence of atrial high rate episode', 'timeFrame': '12 months', 'description': 'factors including biomarkers such as FGF-23 and soluble ST-2, and single nucleotide polymorphism'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial High Rate Episode', 'Cardiac Implantable Electronic Device']}, 'descriptionModule': {'briefSummary': 'This study is sought to investigate any predictors including biomarkers for atrial high rate episodes (AHRE) occurrence in patients without prior history of atrial tachyarrhythmias receiving cardiac implantable electronic device (CIED).', 'detailedDescription': 'Atrial high rate episodes (AHRE) are noticed up to 70% in patients receiving cardiac implantable electronic device (CIED) even in the absence of prior history of atrial tachyarrhythmias. AHRE is clinically important because it is considered to be associated with clinical atrial fibrillation, stroke, mortality, and heart failure hospitalization. Therefore, predictors of AHRE might be useful for early detection of AHRE susceptable CIED recipients. Biomarkers as well as clinical characteristics will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving cardiac implantable electronic device for any clinical indication (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients receiving cardiac implantable electronic device\n\nExclusion Criteria:\n\n* patients who disagree for blood sampling to analyze not commonly used clinical biomarkers\n* patients not followed-up at least 12 months after implanting device'}, 'identificationModule': {'nctId': 'NCT05475860', 'briefTitle': 'Biomarkers Predicting Atrial High Rate Episodes in Cardiac Implantable Electronic Device Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Hospital'}, 'officialTitle': 'Predictors of Atrial High Rate Episodes in Patients Implanting Cardiac Implantable Electronic Device Based on Biomarkers', 'orgStudyIdInfo': {'id': 'H-1803'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients receiving cardiac implantable electronic device', 'description': 'Patients receiving cardiac implantable electronic device for any clinical indication', 'interventionNames': ['Device: implantable cardiac electronic device recipients']}], 'interventions': [{'name': 'implantable cardiac electronic device recipients', 'type': 'DEVICE', 'otherNames': ['pacemaker', 'implantable cardioverter-defibrillator', 'cardiac resynchronization therapy'], 'description': 'implantable cardiac electronic device recipients for any clinical indication', 'armGroupLabels': ['Patients receiving cardiac implantable electronic device']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Jinhee Ahn', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'centralContacts': [{'name': 'Jinhee Ahn, MD', 'role': 'CONTACT', 'email': 'reinee7@gmail.com', 'phone': '82-10-4840-5563'}], 'overallOfficials': [{'name': 'Jinhee Ahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical associate professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical associate professor', 'investigatorFullName': 'Jinhee Ahn, MD', 'investigatorAffiliation': 'Pusan National University Hospital'}}}}