Advocate Aurora Research Institute investigators have joined the PROTECT IV clinical trial with the goal of optimizing future treatment and improving patient health by evaluating a group of medical devices used to treat high-risk people with complex coronary heart disease.
Coronary artery disease is caused by an accumulation of plaque on the walls of arteries that carry life-sustaining blood to the heart muscle. As the unhealthy plaque builds up, the arteries often become narrowed, and sometimes completely blocked, potentially leading to a heart attack or heart failure.
A minimally invasive treatment called percutaneous coronary intervention (PCI) is commonly used to open narrowed or blocked arteries.
“Sometimes additional devices are needed during PCI for people with complex coronary artery disease who are considered high-risk due to the level of their heart disease,” said cardiologist Thomas Levin, MD, the study’s principal investigator for the Research Institute at Advocate Christ Medical Center in Oak Lawn, Illinois. “In these cases, temporary devices are used to assist a weakened heart muscle to pump blood while the artery is widened or the blockage is removed.”
PROTECT IV will evaluate the effectiveness of PCI with an Impella® device compared to the traditional standard of care. For participants in the treatment arm of the study, their doctor will decide which of three Impella® devices (Impella 2.5®, Impella CP® and Impella CP® with SmartAssist®) is most appropriate to use in the procedure. Participants in the control arm of the study will receive the traditional standard of care, which is to undergo PCI on its own or PCI with the use of an intra-aortic balloon pump.
“An Impella® device works like a tiny propeller that helps to keep the blood flowing from the heart to the body,” said cardiologist Louie Kostopoulos, MD, the study’s principal investigator for the Research Institute at Aurora St. Luke’s Medical Center in Milwaukee. “Balloon pumps, on the other hand, help to move blood by expanding when the heart is at rest and deflating when the heart is pumping.”
All of the devices used in the trial have been approved by the U.S. Food and Drug Administration. But a large randomized clinical trial is needed to determine which treatment option is most effective for people with complex coronary heart disease and reduced left-sided heart function, as measured by improvement in symptoms, heart function and health after the procedure. PROTECT IV is the largest such clinical trial open to date, with an expected enrollment of more than 1,250 research participants throughout the world.
“Clinical trials, like PROTECT IV, are needed to ensure we’re providing the most optimal care,” said Laura Wrona, MSN, director of the Center of Excellence in Cardiovascular Research. “Results from this trial will translate into improvements in the care we deliver, and, most importantly, better health outcomes for our patients.”
The clinical trial, also known by its formal title, “Impella®-supported PCI in high-risk patients with complex coronary artery disease and reduced left ventricular function: the PROTECT IV trial,” is sponsored by Abiomed Inc.
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About Advocate Aurora Research Institute
Advocate Aurora Research Institute is a not-for-profit, limited liability company of Advocate Aurora Health. Advocate Aurora has emerged as a national destination for patient-centered bench, translational and clinical research, and the Research Institute unifies the innovative research efforts throughout the health system. Advocate Aurora researchers focus on rapidly translating new discoveries from the scientist’s bench to the patient’s bedside and into the community we serve to improve options and outcomes that change not only the lives of individuals, but transform the health of populations.