November 21, 2019—(BRONX, NY)—Lower extremity arterial disease (LEAD) is a debilitating but under-recognized condition usually caused by fatty plaque buildup in arteries carrying blood from the heart to the legs.  More commonly known as peripheral artery disease, this increasingly common condition affects more than 8 million Americans, including up to 20% of those over the age of 60, and over 200 million people worldwide. Left untreated, LEAD can result in disability, amputations, and death.

Now, researchers at Albert Einstein College of Medicine and Montefiore Health System have received a five-year, $8 million grant from the National Institutes of Health to use mobile health technology to identify early symptoms of LEAD so that it can be promptly diagnosed and treated.

“One reason LEAD is such a problem is that it’s typically not diagnosed until people go to the doctor complaining of cramping or pain while walking,” explained Robert Kaplan, Ph.D., professor of epidemiology and population health at Einstein and principal investigator on the grant. “People often don’t take these symptoms very seriously, especially since the discomfort usually goes away when they stop moving. So they put off seeing their doctor.”

Robert C. Kaplan, Ph.D.Faculty ProfileResearch Profile

Even before life-threatening events occur, LEAD can significantly worsen a person’s mobility and quality of life.

“We want to see if there are any early signals from the body that we can use to improve screening and initiate treatment earlier,” said Dr. Kaplan, who also holds the Dorothy and William Manealoff Foundation and Molly Rosen Chair in Social Medicine. Dr. Kaplan is collaborating on this study with co-principal investigator, Kunihiro Matsushita, M.D., Ph.D., at Johns Hopkins Bloomberg School of Public Health.

The researchers will first conduct LEAD screening on approximately 6,000 participants in the Study of Latinos/Hispanic Community Health Study (SOL/HCHS). They will undergo standard diagnostic tests, including the ankle-brachial index test and the toe-brachial index test, which compare the blood pressure between the ankle and arm and toe and arm, respectively. Known risk factors for LEAD, such as diabetes and smoking, will also be noted.

Participants will then be fitted with physical activity monitors, known as accelerometers. These wrist watches will measure not only the amount of activity but also patterns of activity throughout the day, over seven days.

By comparing the results of the monitors with the results of the diagnostic tests, researchers hope to identify tell-tale patterns of activity that are associated with LEAD. “We expect that these monitors will pick up subtle signals—perhaps more frequent breaks between shorter bouts of activity—that are associated with LEAD,” explained Dr. Kaplan.

We want to see if there are any early signals from the body that we can use to improve screening and initiate treatment earlier.

Robert C. Kaplan, Ph.D.

The 16,000 participants in SOL/HCHS study are enrolled at four sites in the U.S., including the Bronx (Einstein’s site), Miami, San Diego, and Chicago. Those taking part in the LEAD study are over age 45 and scheduled for regular check-ups between 2020 and 2022.

“Some Hispanic groups, including those of Puerto Rican and Cuban descent, have an elevated risk for LEAD, but we don’t know if this is due to a genetic predisposition or behaviors or some combination of both,” said Dr. Kaplan. “We hope to have a clearer picture of those issues at the end of this study and expect that our findings regarding LEAD to be applicable to all people, regardless of ethnicity.”

The grant, titled “PASOS: Peripheral Artery Disease Study of SOL: An Ancillary Study of the Hispanic Community Health Study/Study of Latinos,” was awarded by the National Heart, Lung, and Blood Institute, part of the NIH (1R01HL146132).