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Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

NCT ID: NCT05444335

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-15

Study Completion Date

2026-07-15

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.

Conditions

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Atrial Fibrillation New Onset

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention arm

Women older than 70 who would wear the Zio patch for 2 weeks

Group Type OTHER

Wearable cardiac monitor -Zio patch

Intervention Type DEVICE

Women older than 70 years old will be asked to wear a cutaneous cardiac monitor for 2 weeks.

Interventions

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Wearable cardiac monitor -Zio patch

Women older than 70 years old will be asked to wear a cutaneous cardiac monitor for 2 weeks.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

70 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Prachi Mehndiratta

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prachi Mehndiratta, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Prachi Mehndiratta, MBBS

Role: CONTACT

Phone: 410-328-4170

Email: [email protected]

Seemant Chaturvedi, MD

Role: CONTACT

Phone: 410-328-5803

Email: [email protected]

Facility Contacts

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Prachi Mehndiratta

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 29455950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29438086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33625468 (View on PubMed)

Other Identifiers

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HP-00099005

Identifier Type: -

Identifier Source: org_study_id