SAFE-W: Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05444335
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation New Onset	Device: Wearable cardiac monitor -Zio patch	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years
• Actual Study Start Date: Jun 15, 2022
• Anticipated Primary Completion Date: Jul 15, 2023
• Anticipated Study Completion Date: Jul 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention arm Women older than 70 who would wear the Zio patch for 2 weeks	Device: Wearable cardiac monitor -Zio patch; Women older than 70 years old will be asked to wear a cutaneous cardiac monitor for 2 weeks.

Outcome Measures

Primary Outcome Measures

1. Rate of detection of atrial fibrillation [1 year]

   Percentage of women older than 70 found to have atrial fibrillation one year from enrollment

2. Anticoagulant use for prevention of stroke [2 years]

   Rate of anticoagulant prescription

Secondary Outcome Measures

1. Device adherence [1 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Female sex

2. No previous diagnosis of atrial fibrillation

3. Age ≥70 years

4. CHA2DS2-VASc score ≥4

Exclusion Criteria:

1. Life expectancy < 2 years

2. Dementia or other neurologic condition which would make outpatient follow-up difficult

3. CHA2DS2-VASc score ≤3

4. Any compliance issues - such as heavy alcohol/drug use that would impede follow up.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland Medical Center	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• University of Maryland, Baltimore

Investigators

• Principal Investigator: Prachi Mehndiratta, MBBS, University of Maryland School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grünhagen 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.
• Madsen TE, Howard VJ, Jiménez 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. Review.

• Responsible Party: Prachi Mehndiratta, Assistant Professor, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT05444335
• Other Study ID Numbers: HP-00099005
• First Posted: Jul 5, 2022
• Last Update Posted: Jul 5, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Jul 5, 2022