Screening for Atrial Fibrillation in Native AmeRicans Using iPhone ECG
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

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.
    


Intervention name(s): ECG
Intervention type(s): Diagnostic Test
Intervention description(s): Eligible participants will receive a 30-second ECG recording during their visit at the Absentee Shawnee Tribal clinic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention