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Technology and health: Novel clinical trial reveals new way to diagnose people at risk of stroke, heart attack

March 12, 2018 | Clinical Trial Services

Use of an electrocardiogram (ECG) monitoring skin patch can improve the diagnosis of irregular heartbeat by nearly three-fold over a year compared to standard care – findings that suggest it may be possible to dramatically reduce the incidence of strokes, according to a recent study. The researchers also found that the unique clinical trial format — a collaboration among Aetna’s Healthagen Outcomes, Janssen Scientific Affairs and The Scripps Research Institute — was not only efficient, but also led to increased engagement with participants.

Findings from the “mHealth Screening To Prevent Strokes” (mSToPS) study were announced and discussed at the American College of Cardiology’s annual meeting on March 10.

Atrial fibrillation is an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications, according to the American Heart Association. The condition can be “silent,” which means a person may have the condition, but is unaware because they can’t feel it.

“Finding a silent atrial fibrillation can literally be a lifesaving measure,” said Van Crocker, President of Aetna’s Healthagen Outcomes.

Using Aetna claims data, the researchers identified people who qualified as a potential participant for the mSToPS trial. Over 52,000 people were invited to participate in the study via e-mail, and 50,000 were invited by direct mail. Digital outreach enabled researchers to approach a large, geographically diverse population of at-risk individuals and include people who otherwise may have no access to participation in clinical trials because they don’t live close to a research center.

The participants were asked to wear an iRhythm Zio XT®, an FDA-approved, single-use, water-resistant, 14-day ambulatory ECG monitoring skin patch. The patch monitors and retains information about a person’s continuous heartbeat for up to two weeks. After wearing the patch for two weeks, participants mailed the patches back, with the reports analyzed by the The Scripps Research Institute team.

A total of 1,738 people participated and wore a patch to be actively monitored; 3,476 others served as matched controls.

Over a year of follow-up, researchers discovered 109 new cases of atrial fibrillation. The findings suggest that spot checking for atrial fibrillation – through random pulse checks for irregularity or obtaining a brief electrocardiogram – would miss the vast majority of individuals with undiagnosed atrial fibrillation.

“Because strokes occur so frequently and are often fatal, it is reasonable to believe that you are changing the course of the disease for those diagnosed, or even saving lives,” Crocker said of the trial’s findings.

The digital technology used in the clinical trial allowed the research to be more inclusive and focused on participants. By utilizing a combination of Aetna’s claims data to identify individuals at risk of irregular heartbeat, a website and proactive emails to potential participants and the ECG skin patch, the researchers were able to approach at-risk individuals at a much larger scale.

“Pre-qualifying participants who might be at risk for a condition like atrial fibrillation — vs. casting a wide net across the general population and hoping for the best — is absolutely the best way to enable research in a real-world setting,” Crocker said.

Steven Steinhubl, M.D., director of digital medicine at the Scripps Translational Science Institute, agreed that the study pushes the boundaries of clinical research.

“We hope that this study will move the modern clinical research field forward, as an early indicator of what is possible via real-world, participant-centric clinical trials enabled through digital medicine technologies,” Steinhubl said.