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NCT03740477 · ClinicalTrials.gov registry record · NA
Screening for Atrial Fibrillation in Native AmeRicans Using iPhone ECG
A NA study, sponsored by University of Oklahoma.
- Completed
- Registry status
- NA
- Development phase
- 1,019
- Enrollment target
NCT03740477 is a NA study that has completed, run by University of Oklahoma. The registered enrollment target is 1,019 participants.
The verdict
NCT03740477, a NA study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,019 participants
- Enrollment target
Study 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 devic
Interventions
- DIAGNOSTIC_TEST ECG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,019 participants |
| Start Date | 2018-12-03 |
| Est. Completion | 2020-10-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03740477
The ClinicalTrials.gov registry entry for NCT03740477 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,019 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ECG is the first listed.
NCT03740477 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03740477 about?
NCT03740477 is a clinical study titled "Screening for Atrial Fibrillation in Native AmeRicans Using iPhone ECG". 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 ...
What is the current status of trial NCT03740477?
This trial is currently completed. It is a NA study. The enrollment target is 1,019 participants. The study started on 2018-12-03. Estimated completion is 2020-10-31.
What interventions are being tested in trial NCT03740477?
The interventions under investigation include: ECG (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03740477?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
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