Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

Study Overview
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Brief Summary
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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
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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.

Official Title
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Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

Conditions
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Atrial Fibrillation New Onset

Intervention / Treatment
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* Device: Wearable cardiac monitor -Zio patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female sex No previous diagnosis of atrial fibrillation Age ≥70 years CHA2DS2-VASc score ≥4 Exclusion Criteria: Life expectancy < 2 years Dementia or other neurologic condition which would make outpatient follow-up difficult CHA2DS2-VASc score ≤3 Any compliance issues - such as heavy alcohol/drug use that would impede follow up.

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of detection of atrial fibrillation | Percentage of women older than 70 found to have atrial fibrillation one year from enrollment | 1 year | 
| Anticoagulant use for prevention of stroke | Rate of anticoagulant prescription | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |