iRhythm Technologies (NSDQ:IRTC) announced that it is participating in a new Bristol-Myers Squibb–Pfizer (NYSE:PFE) Alliance study for reducing stroke by screening for undiagnosed atrial fibrillation in elderly individuals.
The goal of the “Guard-AF” study is to determine if earlier detection of AFib can impact the rate of stroke through screening previously undiagnosed people who are at least 70 years old in the U.S. The screening arm is slated to use iRhythm’s Zio XT electrocardiogram monitoring system.
iRhythm said the 52,000-person Guard-AF study population will include men and women at least 70 years of age visiting their primary care physician for standard follow-up care. The company plans to randomize patients to receive Zio XT or receive standard care and expects enrollment to begin in the coming weeks.
The primary outcome measures are stroke and bleeding events leading to hospitalization. iRhythm added that it will use a novel approach in which outcome events are ascertained from a healthcare claims database, which could offer evidence on health outcomes associated with AFib detection intervention that may help inform future guidelines.
San Francisco-based iRhythm added that a study published in JAMA last year revealed that patients diagnosed with AFib in iRhythm’s Zio service-monitored group had a significantly lower rate of hospitalizations and emergency room visits in the following 12 months compared to the non-monitored control group.
“iRhythm is excited to participate in the Guard-AF study with the Alliance,” iRhythm president & CEO Kevin King said in a news release. “This is an important study to determine whether monitoring of individuals at-risk of AFib can ultimately lead to improved outcomes and decreased rates of stroke. We are pleased to be involved in the study and contributing to this important clinical research in an area of unmet need.”
“Through earlier AFib detection, we’re focused on helping to reduce the number of individuals who suffer an AFib-related stroke,” said Roland Chen, VP and head of clinical development, Innovative Medicines, Bristol-Myers Squibb. “With this study, the BMS-Pfizer Alliance intends to help inform clinical practice regarding screening for this common type of heart rhythm condition.”