Scripps starts massive study to find undiagnosed AFib using iRhythm wearable patch

ZIO XT Patch--Courtesy of iRhythm

The Scripps Translational Science Institute (STSI) has launched a study of up to 6,100 patients using a wearable patch for continuous cardiovascular monitoring that's intended to identify asymptomatic atrial fibrillation (AFib) patients. A type of heart arrhythmia, AFib raises stroke risk by roughly five-fold and is associated with other health complications.

The expectation is that undergoing continuous single-lead electrocardiogram (ECG) monitoring with the ZIO XT Patch wearable sensor from iRhythm Technologies will better identify asymptomatic AFib patients than routine care such as regular visits to a primary care doctor. The study will be conducted over a 4-month period, with continuous monitoring occurring in the first two weeks and the last two weeks of that timeframe.

"This is a uniquely targeted and participant-centric trial that takes full advantage of digital technologies, including large medical data sets and wearable sensors," Dr. Steven Steinhubl, director of digital medicine at STSI and principal investigator of the trial, said in a statement. "Once completed, it has the potential to truly change the practice of screening and markedly improve outcomes."

STSI is sponsored by the National Institutes of Health (NIH) and led by Scripps Health in collaboration with The Scripps Research Institute. In September, STSI launched a similarly massive 4,000+ patient study using Scanadu's vital sign monitor.

To conduct the study, STSI has teamed with several parties representing different digital health stakeholders these include insurer Aetna's ($AET) Innovation Labs, the Healthagen Outcomes unit and Johnson & Johnson's ($JNJ) Janssen Pharmaceuticals.

The patients will be recruited for monitoring via the Aetna Commercial Fully Insured and Medicare programs. Up to 2,100 participants will be selected to undergo continuous single-lead ECG monitoring, with an additional 4,000 people slated to serve as observational controls. The population will be drawn from women over age 65 and men older than 55, since those groups have a potentially higher risk of undiagnosed AFib.

A subset of patients in the larger trial, which is dubbed mHealth Screening To Prevent Strokes or mSToPS, will also be invited to participate in a substudy that incorporates heart rate and rhythm monitoring using an Amiigo wristband monitor.

"Digital sensors are a vital part of the future of medicine," STSI Director Dr. Eric Topol said. "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."

Almost one-third of AFib cases are thought to be undiagnosed, with an estimated patient population of about 6 million Americans. Roughly one in three people with AFib have a stroke within their lifetimes.

- here is the announcement

Special Report: iRhythm- 2014 Fierce 15

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