Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT03491202
Status:
UNKNOWN
Last Update Posted:
2018-06-11
First Post:
2018-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Genetic Basis for 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': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-08', 'studyFirstSubmitDate': '2018-04-02', 'studyFirstSubmitQcDate': '2018-04-02', 'lastUpdatePostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms related to atrial fibrillation (chest pain, dyspnea, palpitations)', 'timeFrame': '1 year'}, {'measure': 'heart rate', 'timeFrame': '1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) is reaching epidemic proportions in the aging U.S. and European populations, but the mechanisms of increased susceptibility to atrial fibrillation are still unknown. In this study, we look to further examine genetic and medical co-morbidity influence of atrial fibrillation duration and response to medications. In Specific Aim 1, we propose the creation of a Veterans Affairs AF Biorepository (VAAFBio), which is a resource that will collect and store clinical, demographic, blood and DNA samples from patients with atrial fibrillation to aide this study and future studies of this type in the VA population. In Specific Aim 2, examine common genetic polymorphisms in veteran patients with atrial fibrillation and examine gene-environment interactions with risk factors for atrial fibrillation.', 'detailedDescription': 'Atrial fibrillation (AF) is reaching epidemic proportions in the aging U.S. and European populations, but the mechanisms of increased susceptibility to atrial fibrillation are still unknown. In this study, the investigators look to further examine genetic and medical co-morbidity influence of atrial fibrillation duration and response to medications. In Specific Aim 1, the investigators propose the creation of a Veterans Affairs AF Biorepository (VAAFBio), which is a resource that will collect and store clinical, demographic, blood and DNA samples from patients with atrial fibrillation to aide this study and future studies of this type in the VA population. In Specific Aim 2, the investigators will examine common genetic polymorphisms in veteran patients with atrial fibrillation and examine gene-environment interactions with risk factors for atrial fibrillation.\n\nPatients will be identified through the VA inpatient and outpatient clinic, and will be approached for inclusion in the study. The target enrollment for the research and biorepository is 600 participants. A detailed family history, medical background, study questionnaires and a blood sample will then be obtained by the principal investigator or a research coordinator, following written informed consent under a protocol approved by the Jesse Brown VA Institutional Review Board. Once enough samples are collected, coded DNA samples will be sent out to analyze for linkage to known/candidate loci for AF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be identified in the outpatient clinic or in the inpatient setting at the Jesse Brown VA Medical Center and approached for informed consent and HIPAA authorization.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be at least 18 years of age, and up to 100.\n* Subjects must have a documented history of atrial fibrillation by ECG, ECHO, and or Holter monitor event recorder.\n* Subjects must be willing to give written, informed consent.\n\nExclusion Criteria:\n\n* Patients with a history of AF or atrial flutter that is only associated with cardiac surgery will be excluded from the study.\n* Subjects who cannot speak English will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT03491202', 'briefTitle': 'The Genetic Basis for Atrial Fibrillation', 'organization': {'class': 'FED', 'fullName': 'Jesse Brown VA Medical Center'}, 'officialTitle': 'The Genetic Basis for Atrial Fibrillation', 'orgStudyIdInfo': {'id': '977544'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'atrial fibrillation', 'description': 'Patients with a diagnosis of atrial fibrillation will be eligible for enrollment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katherine A Durham, MS, APN', 'role': 'CONTACT', 'email': 'Katherine.durham@va.gov', 'phone': '312-569-6635'}, {'name': 'Katherine A Durham, MS, APN', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dawood Darbar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jesse Brown VA Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Katherine A Durham, APN', 'role': 'CONTACT', 'email': 'Katherine.durham@va.gov', 'phone': '3125696635'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jesse Brown VA Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiology Nurse Practitioner', 'investigatorFullName': 'Katherine Durham MS, APN', 'investigatorAffiliation': 'Jesse Brown VA Medical Center'}}}}