Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

Atrial Fibrillation New Onset Clinical Trial

— SAFE-W  

Official title:

Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444335
• Other study ID #: HP-00099005
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: July 15, 2025

Study information

• Verified date: December 2023
• Source: University of Maryland, Baltimore
• Contact: Prachi Mehndiratta, MBBS
• Phone: 410-328-4170
• Email: pmehndiratta[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 70 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset

Intervention

Device:
• Wearable cardiac monitor -Zio patch
Women older than 70 years old will be asked to wear a cutaneous cardiac monitor for 2 weeks.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of detection of atrial fibrillation	Percentage of women older than 70 found to have atrial fibrillation one year from enrollment	1 year
Primary	Anticoagulant use for prevention of stroke	Rate of anticoagulant prescription	2 years
Secondary	Device adherence	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.	1 year