Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-31 @ 9:36 PM
Study NCT ID:
NCT05444335
Status:
RECRUITING
Last Update Posted:
2024-12-16
First Post:
2022-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of detection of atrial fibrillation', 'timeFrame': '1 year', 'description': 'Percentage of women older than 70 found to have atrial fibrillation one year from enrollment'}, {'measure': 'Anticoagulant use for prevention of stroke', 'timeFrame': '2 years', 'description': 'Rate of anticoagulant prescription'}], 'secondaryOutcomes': [{'measure': 'Device adherence', 'timeFrame': '1 year', 'description': 'Rate of compliance with device - participants would be asked if they wore the device as advised for the two weeks and adherence would be reported as a percentage.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation New Onset']}, 'referencesModule': {'references': [{'pmid': '29455950', 'type': 'BACKGROUND', 'citation': 'Andrade JG, Deyell MW, Lee AYK, Macle L. Sex Differences in Atrial Fibrillation. Can J Cardiol. 2018 Apr;34(4):429-436. doi: 10.1016/j.cjca.2017.11.022. Epub 2017 Dec 6.'}, {'pmid': '29438086', 'type': 'BACKGROUND', 'citation': 'Madsen TE, Howard VJ, Jimenez M, Rexrode KM, Acelajado MC, Kleindorfer D, Chaturvedi S. Impact of Conventional Stroke Risk Factors on Stroke in Women: An Update. Stroke. 2018 Mar;49(3):536-542. doi: 10.1161/STROKEAHA.117.018418. Epub 2018 Feb 8. No abstract available.'}, {'pmid': '33625468', 'type': 'BACKGROUND', 'citation': 'Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grunhagen D, McIntyre WF, Benz AP, Wong JA, Merali F, Henein S, Nichol C, Connolly SJ, Healey JS; SCREEN-AF Investigators and Coordinators. Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. 2021 May 1;6(5):558-567. doi: 10.1001/jamacardio.2021.0038.'}]}, 'descriptionModule': {'briefSummary': 'Screening for Atrial Fibrillation in Elderly Women (SAFE-W) is a pilot study evaluating the prevalence of atrial fibrillation (Afib) in a rapidly aging segment of the population. Studies have shown that women with Afib are more likely to be symptomatic, have increased mortality from stroke resulting from Afib, and are less likely to receive treatment for Afib. University of Maryland Department of Neurology and Vascular Neurology are recruiting women older than 70 years of age to participate in the study.', 'detailedDescription': 'Atrial fibrillation or irregular heart beat is seen in 1/3rd of patients that present with stroke. Atrial fibrillation is being increasingly seen in women older than 70 as women are likely to live longer. Women are more likely to die from atrial fibrillation related stroke and are more likely to have symptoms from uncontrolled atrial fibrillation. They are also less likely to be treated with blood thinners to prevent stroke. This section of the population has been underrepresented in other studies on atrial fibrillation and the aim of this study is to proactively screen women older than 70 who are at risk for atrial fibrillation by using a wearable cardiac monitor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '70 Years', 'genderBased': True, 'genderDescription': 'Women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female sex\n2. No previous diagnosis of atrial fibrillation\n3. Age ≥70 years\n4. CHA2DS2-VASc score ≥4\n\nExclusion Criteria:\n\n1. Life expectancy \\< 2 years\n2. Dementia or other neurologic condition which would make outpatient follow-up difficult\n3. CHA2DS2-VASc score ≤3\n4. Any compliance issues - such as heavy alcohol/drug use that would impede follow up.'}, 'identificationModule': {'nctId': 'NCT05444335', 'acronym': 'SAFE-W', 'briefTitle': 'Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years', 'orgStudyIdInfo': {'id': 'HP-00099005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention arm', 'description': 'Women older than 70 who would wear the Zio patch for 2 weeks', 'interventionNames': ['Device: Wearable cardiac monitor -Zio patch']}], 'interventions': [{'name': 'Wearable cardiac monitor -Zio patch', 'type': 'DEVICE', 'description': 'Women older than 70 years old will be asked to wear a cutaneous cardiac monitor for 2 weeks.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Prachi Mehndiratta', 'role': 'CONTACT', 'email': 'pmehndiratta@som.umaryland.edu', 'phone': '410-328-5803'}], 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Prachi Mehndiratta, MBBS', 'role': 'CONTACT', 'email': 'pmehndiratta@som.umaryland.edu', 'phone': '410-328-4170'}, {'name': 'Seemant Chaturvedi, MD', 'role': 'CONTACT', 'email': 'schaturvedi@som.umaryland.edu', 'phone': '410-328-5803'}], 'overallOfficials': [{'name': 'Prachi Mehndiratta, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Prachi Mehndiratta', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}