Clinical trial NCT05444335: Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years
Official title: Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation New Onset
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of detection of atrial fibrillation
timeFrame: 1 year
measure: Anticoagulant use for prevention of stroke
timeFrame: 2 years
Secondary outcomes:
measure: Device adherence
timeFrame: 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Prachi Mehndiratta, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.