Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 12:53 AM
Study NCT ID:
NCT03313167
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2017-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate
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': 1316}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-07', 'studyFirstSubmitDate': '2017-10-12', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of subjects screened with AF identified at Index Visit', 'timeFrame': 'Up to 4 weeks'}, {'measure': 'number of subjects screened with AF not identified at Index Visit', 'timeFrame': 'Up to 4 weeks from Index Visit', 'description': 'number of subjects screened who have AF not identified at their Index Visit but subsequently found to have AF confirmed by 12-lead Electrocardiogram (ECG) during the extended monitoring period'}], 'secondaryOutcomes': [{'measure': 'number of subjects with ECG-confirmed AF detected by the Omron BP device', 'timeFrame': 'Day 1 to Day 14', 'description': 'number of subjects with ECG-confirmed AF detected by the Omron blood pressure (BP) device during the extended monitoring period'}, {'measure': 'number of subjects with ECG-confirmed AF detected by MB or HCG-801', 'timeFrame': 'Day 14 to Day 28', 'description': 'number of subjects with ECG-confirmed AF detected by MyBeat (MB) or Omron HeartScan 801 (HCG-801) during the extended monitoring period'}, {'measure': 'number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy', 'timeFrame': '24 week follow up period'}, {'measure': 'number of subjects with AF identified at their Index Visit who are prescribed guideline recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up period', 'timeFrame': 'At week 24'}, {'measure': 'number of subjects with Paroxysmal atrial fibrillation (PAF) identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy', 'timeFrame': 'Day 1 to Day 28'}, {'measure': 'number of subjects with PAF identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up', 'timeFrame': 'At week 24'}, {'measure': 'number of subjects with AF identified at the Index Visit who had an ischemic stroke during the 24-week follow-up period', 'timeFrame': 'Index Visit up to week 24'}, {'measure': 'number of subjects with PAF identified during the extended monitoring period who had an ischemic stroke during the 24-week follow-up period', 'timeFrame': 'Day 1 up to week 24'}, {'measure': 'number of subjects with AF identified at the Index Visit who bled during the 24-week follow-up period', 'timeFrame': 'Index Visit up to week 24'}, {'measure': 'number of subjects with PAF identified during the extended monitoring period who bled during the 24-week follow-up period', 'timeFrame': 'Day 1 up to week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'To assess the prevalence of all (prevalent and paroxysmal) undiagnosed atrial fibrillation (AF) in a Japanese population with a moderate-to-high risk of stroke'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Japanese population with a moderate-to high risk of stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65 and one or more of the following: hypertension, prior stroke or transient ischemic attack, congestive heart failure, diabetes mellitus, and/or vascular disease\n\nExclusion Criteria:\n\n* Age \\< 65 years, individuals with AF or a history of AF, or individuals taking anti-arrhythmic drugs\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03313167', 'briefTitle': 'Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF)', 'orgStudyIdInfo': {'id': 'CV185-595'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atrial Fibrillation-potential Patients', 'description': 'individuals 65 years of age or older with moderate-to-high risk of stroke', 'interventionNames': ['Other: Non-interventional']}], 'interventions': [{'name': 'Non-interventional', 'type': 'OTHER', 'description': 'Non-interventional', 'armGroupLabels': ['Atrial Fibrillation-potential Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '173-0003', 'city': 'Itabashi-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}