Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-28 @ 4:30 PM
Study NCT ID:
NCT04786366
Status:
UNKNOWN
Last Update Posted:
2021-03-08
First Post:
2020-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural History and Patient Journey in Atrial Fibrillation: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5601803}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1998-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Atrial fibrillation', 'timeFrame': 'Jan 1st 1998 - May 31st 2016', 'description': 'AF incidence in the population'}, {'measure': 'Mortality of Atrial fibrillation', 'timeFrame': 'Jan 1st 1998 - May 31st 2016', 'description': 'Mortality among AF patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'healthcare contacts', 'Electronic Health Records', 'epidemiology', 'comorbidity', 'health inequality'], 'conditions': ['Atrial Fibrillation', 'Epidemiology']}, 'referencesModule': {'references': [{'pmid': '37840952', 'type': 'DERIVED', 'citation': 'Chung SC, Schmit AF, Lip GYH, Providencia R. Electronic health record-wide association study for atrial fibrillation in a British cohort. Front Cardiovasc Med. 2023 Sep 28;10:1204892. doi: 10.3389/fcvm.2023.1204892. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The trajectory of atrial fibrillation (AF) patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the AF incidence, mortality and case-fatality, the investigators implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK from 1998 to 2016 (CALIBER). A matched case-control study design was used to investigate the causes of hospitalization and death comparing individuals with and without incident AF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators implement two study designs, first a longitudinal cohort study to assess AF incidence and second a matched case-control study for mortality, cause of death and hospitalization.\n\nThe investigators identify individuals aged 18 years or older and registered in the current primary care practice for at least one year. Individuals are excluded if they had a prior history of AF before study entry. For the nested case-control study, controls are matched to incident AF patients according to sex and age (10-year age strata).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The investigators identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.\n\nExclusion Criteria:\n\n* Individuals are excluded if they had a prior history of AF before study entry.'}, 'identificationModule': {'nctId': 'NCT04786366', 'briefTitle': 'Natural History and Patient Journey in Atrial Fibrillation: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Natural History and Patient Journey in Atrial Fibrillation: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.', 'orgStudyIdInfo': {'id': 'ISAC17_205'}}, 'armsInterventionsModule': {'interventions': [{'name': 'The study does not have an intervention, but observe the AF incidence of the UK disease-free population', 'type': 'OTHER', 'description': 'The study does not have an intervention, but observe the AF incidence of the UK disease-free population.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}