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Screening for Atrial Fibrillation in Native AmeRicans Using iPhone ECG (SAFARI)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ECG
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged 50 or older

Exclusion Criteria:

  • Known history of atrial fibrillation

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intrevention

Arm Description

Eligible participants will receive a 30-second smartphone-based ECG

Outcomes

Primary Outcome Measures

incidence of newly diagnosed atrial fibrillation

Secondary Outcome Measures

prevalence of guideline-directed anticoagulant use among participants who are found to have atrial fibrillation

Full Information

First Posted
November 9, 2018
Last Updated
April 22, 2021
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT03740477
Brief Title
Screening for Atrial Fibrillation in Native AmeRicans Using iPhone ECG
Acronym
SAFARI
Official Title
Screening for Atrial Fibrillation in Native AmeRicans Using iPhone ECG (SAFARI)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Atrial fibrillation (AF) is the most common clinically significant arrhythmia and is associated with increased rates of stroke, heart failure, mortality, hospitalization, and cognitive decline. Approximately one third of ischemic strokes are attributable to either previously known or newly detected AF at the time of stroke. Many AF episodes are asymptomatic and stroke is the first manifestation of AF in at least 25% of AF-related strokes. Anticoagulation for AF leads to a reduction in stroke to levels similar to matched individuals without AF. Therefore, identifying AF in an earlier asymptomatic state (i.e. screening for silent AF), with subsequent initiation of anticoagulation in at-risk individuals, may decrease the risk of future thromboembolic events. The availability of inexpensive smartphone-based or handheld ECG devices that rapidly acquire a cardiac rhythm strip of quality comparable to a traditional 12-lead ECG have markedly enhanced the feasibility of AF screening. Native Americans have a high prevalence of diabetes and higher incidence of stroke than whites and blacks. Our central hypothesis is that screening for AF using a single time point, 30-second iPhone-based ECG recording over 2 weeks will result in identification of silent AF in a significant number of individuals at risk for stroke compared to routine care (no screening) and will thus lead to improved outcomes through initiation of anticoagulation. The aim of this study is to screen for AF in Native Americans who are seen at the Absentee Shawnee Tribal clinic using a smartphone-based ECG device. Individuals who are at least 50 years old and have no prior history of AF will be eligible for enrollment in the study. Eligible participants will receive a 30-second ECG recording during their visit at the Absentee Shawnee Tribal clinic. The device has an algorithm for diagnosis of AF, which is 98% sensitive and 97% specific. A cardiologist will overread the tracings that are diagnosed by AF by the device. Those confirmed to have AF will be referred to a cardiologist for further evaluation and management. The clinical characteristics of those who are found to have AF will be compared with those who are not, in order to identify risk factors for AF. Newly diagnosed AF using this method is expected to be approximately 2.5%. We aim to include a total of 1,500 participants over 12 months. The proposed study will provide the basis for the design of further intervention studies using mobile technology to improve the health of Native Americans and other minority populations. In light of the high prevalence of risk factors for AF in Native Americans and the association of silent AF with stroke, this novel approach for AF screening has the potential to impact clinical practice and improve health outcomes among a large number of individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1019 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrevention
Arm Type
Experimental
Arm Description
Eligible participants will receive a 30-second smartphone-based ECG
Intervention Type
Diagnostic Test
Intervention Name(s)
ECG
Intervention Description
Eligible participants will receive a 30-second ECG recording during their visit at the Absentee Shawnee Tribal clinic
Primary Outcome Measure Information:
Title
incidence of newly diagnosed atrial fibrillation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
prevalence of guideline-directed anticoagulant use among participants who are found to have atrial fibrillation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 50 or older Exclusion Criteria: Known history of atrial fibrillation
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33878888
Citation
Stavrakis S, Elkholey K, Lofgren MM, Asad ZUA, Stephens LD, Freedman B. Screening for Atrial Fibrillation in American Indian Adults in a Tribal Primary Care Clinic. J Am Heart Assoc. 2021 May 4;10(9):e020069. doi: 10.1161/JAHA.120.020069. Epub 2021 Apr 21.
Results Reference
derived

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Screening for Atrial Fibrillation in Native AmeRicans Using iPhone ECG

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