Release Date: March 10, 2020
BUFFALO, N.Y. — The statistics are alarming: Every 40 seconds, someone in the United States has a stroke. Every four minutes, a stroke victim dies.
According to the Centers for Disease Control and Prevention, approximately one out of every 20 deaths in the U.S. — or 140,000 fatalities annually — is a caused by stroke.
One of the leading causes of stroke is atrial fibrillation, or AFib, which is a quivering or irregular heartbeat. The American Heart Association estimates that at least 2.7 million Americans are living with AFib. Unfortunately, many patients are unaware they have the condition, or just how serious it is.
A new, three-year national study will explore whether earlier diagnosis of the condition, combined with appropriate treatment, can improve health outcomes — including reducing the risk of stroke.
The Heartline Study, a collaboration between Johnson & Johnson and Apple, is a first-of-its kind, virtual study designed to explore whether an iPhone app and Apple Watch can help reduce the risk of stroke by regularly monitoring study participants’ heart rhythms.
“We know that atrial fibrillation leads to stroke,” said Anne B. Curtis, MD, Charles and Mary Bauer professor and chair and SUNY Distinguished Professor in the Department of Medicine in the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, who is serving on the Heartline Study Executive Committee.
“What we hope to learn here is whether diagnosing AFib early, before a patient even knows he or she has it, and instituting treatment can prevent future strokes,” added Curtis, who has a long-standing interest in digital health and has conducted previous studies on AFib detection.
The virtual study model is designed to break down some of the barriers to participation in traditional “brick and mortar” studies. It will allow participants to take part in the study remotely, without time-consuming and often costly trips to clinical testing sites. Thus, it will help to ensure participation by a broader, more inclusive group of subjects.
Study organizers expect to recruit 150,000 participants from across the country. Information about the study website is being circulated to physicians through social media, said Curtis.
The 13 members of the committee also are spreading the word in their own communities. The committee includes representatives from such institutions as Northwestern University, Stanford University, University of Missouri, Duke University, Harvard and the Cleveland Clinic.
To be eligible to participate in the study, applicants must be age 65 or older, a U.S. resident for the period of the study, be able to read and understand English, have Original (traditional) Medicare, have an iPhone 6s or a later model (with iOS version 12.2 or later), and agree to provide access to their Medicare claims data.
Eligible participants will be randomly assigned to one of two groups. One group will participate by only using the Heartline Study app on their iPhone. The other group will participate by using the study app on their iPhone in addition to using an Apple Watch (which they may lease if they do not own one) to access the watch’s ECG app and irregular rhythm notification feature.
The study will consist of two years of active engagement followed by one year of additional data collection.
During the course of the study, participants’ heart rhythms will be routinely monitored, and it is hoped that increased awareness will lead to better compliance with appropriate treatments. Data will be stored on participants’ phones and then transmitted securely to a third-party representative for storage, Curtis said.
In addition, participants will receive educational materials, surveys and questionnaires on a weekly basis.
The study will measure the impact of educational materials delivered via the Apple devices, as well as the impact of an earlier diagnosis on clinical outcomes. It will also build a longitudinal health data repository containing all study data.
Curtis hopes doctors in Western New York will encourage eligible patients to participate in the study.
“We do have a higher-risk population in Western New York, as atrial fibrillation is more common in older patients, obese patients, and those with heart failure, sleep apnea and hypertension,” she said. “Undiagnosed, it can lead to stroke.”