Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-04-08 @ 1:14 PM
Study NCT ID:
NCT00599118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2008-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Genetic, Biochemical and Hormonal Factors Contributing to Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma, serum, buffy coat, DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2008-01-10', 'studyFirstSubmitQcDate': '2008-01-11', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genetic variants associated with atrial fibrillation', 'timeFrame': 'Baseline', 'description': 'Genome-wide association study of atrial fibrillation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Genetics'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish a genebank repository of blood samples and data to generate information about the hereditary (genetic) basis of atrial fibrillation.', 'detailedDescription': 'Blood samples and data will be collected from subjects with atrial fibrillation and normal controls. The primary aim of future research using these samples is to identify mechanisms and pathogenesis of atrial fibrillation. Through this information, we hope to identify targets for new therapies and improve knowledge and understanding of atrial fibrillation. Identification of disease genes could improve strategies that prevent progression of atrial fibrillation to more persistent disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with atrial fibrillation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Atrial Fibrillation group:\n\n* Male or female at least 18 years old\n* Subjects with a history of or current Atrial Fibrillation\n* Subjects able to give informed consent Exclusion Criteria for Atrial Fibrillation group: no history of atrial fibrillation\n\nInclusion Criteria for Controls:\n\n* Male or female at least 18 years old\n* Subjects with no history of Atrial Fibrillation\n* Subjects able to give informed consent Exclusion Criteria for controls: History of atrial fibrillation'}, 'identificationModule': {'nctId': 'NCT00599118', 'briefTitle': 'Identification of Genetic, Biochemical and Hormonal Factors Contributing to Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Identification of Genetic, Biochemical and Hormonal Factors Contributing to Atrial Fibrillation', 'orgStudyIdInfo': {'id': '8271'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'atrial fibrillation', 'description': 'Atrial fibrillation'}, {'label': 'Control', 'description': 'Control subjects with no atrial fibrillation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44145', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinical Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Mina K Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mina Chung, MD', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}