According to CDC www.cdc.gov as many as six million Americans live with Atrial Fibrillation (AFib) which is an irregular heartbeat that can lead to a five-fold increased risk of stroke and other severe health related complications.
While effective therapies exist to help reduce the risk of stroke in patients with AFib, the condition remains notably underdiagnosed. With as many as 30 percent of all cases of AFib undiagnosed, more effective methods are needed to screen for AFib.
The Scripps Translational Science Institute (STSI) www.scripps.org is a consortium sponsored by NIH www.nih.gov and led by Scripps Health in collaboration with the Scripps Research Institute. This partnership enables Scripps to lead the effort to translate wireless and genetic medical technologies into high quality cost effective treatments and diagnostics for patients.
Researchers at STSI have launched a home-based clinical trial that uses wearable sensor technology to identify people with asymptomatic AFib. The primary objective of the study titled “mHealth Screening to Prevent Strokes” (mSToPS) is to determine whether screening select individuals in their homes using wearable sensor technology can identify people with asymptomatic AFib more efficiently than routine care.
STSI has teamed with Aetna’s Innovation Labs www.aetna.com, Healthagen www.healthgen.com, and Janssen Pharmaceuticals www.janssen.com to conduct the study. Up to 2,100 participants will be recruited for active monitoring through the Aetna’s Commercial Fully Insured and Medicare programs with an addition 4,000 people to be identified as observational controls.
During the four month monitoring period, participants will undergo continuous single-lead ECG monitoring using the ZIO XT Patch wearable sensor developed by iRhythm Technologies www.irhythmtech.com for the first two weeks and the last two weeks of the monitoring period.
In order to explore multiple innovative technologies for heart rhythm detection, a subset of participants will also participate in a sub-study to monitor heart rate and rhythm characteristics through the Amiigo wristband monitor for a period of four months.
“This is a uniquely targeted and participant-centric trial that takes full advantage of digital technologies, including large medical data sets and wearable sensors,” reports Steven Steinhubl, MD, Director of Digital Medicine at STSI and Principal Investigator of the mSToPS trial.
“Digital sensors are a vital part of the future of medicine. The mSToPS trial has the potential to upgrade and refine our approach in screening for heart arrhythmias, and at the same time, demonstrate the value of large real world clinical trials using an array of digital medicine technologies”, according to STSI Director Eric Topol, MD.