Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years (SAFE-W)
Primary Purpose
Atrial Fibrillation New Onset
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wearable cardiac monitor -Zio patch
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation New Onset
Eligibility Criteria
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.
Sites / Locations
- University of Maryland Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention arm
Arm Description
Women older than 70 who would wear the Zio patch for 2 weeks
Outcomes
Primary Outcome Measures
Rate of detection of atrial fibrillation
Percentage of women older than 70 found to have atrial fibrillation one year from enrollment
Anticoagulant use for prevention of stroke
Rate of anticoagulant prescription
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05444335
First Posted
June 22, 2022
Last Updated
July 18, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT05444335
Brief Title
Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years
Acronym
SAFE-W
Official Title
Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation New Onset
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Other
Arm Description
Women older than 70 who would wear the Zio patch for 2 weeks
Intervention Type
Device
Intervention Name(s)
Wearable cardiac monitor -Zio patch
Intervention Description
Women older than 70 years old will be asked to wear a cutaneous cardiac monitor for 2 weeks.
Primary Outcome Measure Information:
Title
Rate of detection of atrial fibrillation
Description
Percentage of women older than 70 found to have atrial fibrillation one year from enrollment
Time Frame
1 year
Title
Anticoagulant use for prevention of stroke
Description
Rate of anticoagulant prescription
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Device adherence
Description
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.
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prachi Mehndiratta, MBBS
Phone
410-328-4170
Email
pmehndiratta@som.umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Seemant Chaturvedi, MD
Phone
410-328-5803
Email
schaturvedi@som.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prachi Mehndiratta, MBBS
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prachi Mehndiratta
Phone
410-328-5803
Email
pmehndiratta@som.umaryland.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29455950
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.
Results Reference
background
PubMed Identifier
29438086
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.
Results Reference
background
PubMed Identifier
33625468
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.
Results Reference
background
Learn more about this trial
Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years
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