Infraredx Technology: A global study to see heart attacks before they happen - August 23, 2014

Courtesy of NWI Times

August 23, 2014 1:15 pm   •   Julie Kessler Times Correspondent

A Nobel Prize winner and a leader in the research on the causes of heart attacks is excited about a new, large-scale study aimed at preventing heart attacks. He’s also delighted that Methodist Hospitals in Gary and Merrillville are vigorously joining in the effort.

Dr. James Muller is a cardiologist and Chief Medical Officer of Infraredx, a medical device company sponsoring the international study that will include 100 hospitals in 10 countries and 9,000 study participants. A press release from Methodist Hospital said the research, called the Lipid-Rich Plaque (LRP) Study, is aimed at discovering whether there is a link between the presence of LRP — a type of fatty coronary artery plaque — and an increased occurrence of a cardiac event such as a heart attack.

“Methodist Hospital in Gary is one of the world’s leading centers in this large international study we’re doing,” Muller says in an interview in August. Methodist is one of 12 hospitals that have begun enrolling patients in the study; 168 are already enrolled, with a goal of 1,000 for the first part of the study.

“With the first part of this study, we’re trying to predict heart attacks; once prediction is successful, we will try new treatments to prevent these coronary events. Right now, (catheter) labs are treating heart attacks after they have occurred, but in the future we hope that cath labs will be able to prevent them,” Muller says.

What causes heart attacks is understood: It’s the cholesterol accumulating in the arteries. This leads to plaques, which rupture and cause a clot that blocks arteries, Muller said. “We need to find cholesterol in the arteries and assess its size. We know we can find the cholesterol-rich plaques; they show up as a big yellow spot (on the imaging device). What we believe, but is not yet proven, is that the lipid-rich plaque is the plaque that ruptures and causes the heart attack. The cholesterol-rich plaque is indicted but not yet fully convicted.”

Using the terms “lipid-rich plaques” and “cholesterol-rich plaques” interchangeably, Muller says most patients know their cholesterol level, but doctors haven’t been able to tell them how much cholesterol is in the wall of the coronary artery. “That’s what our new technology provides: It can tell you how much cholesterol is in the wall of the artery which we believe is more important than knowing how much cholesterol is in the blood.”

The new technology is Infraredx’s intravascular imaging technology, the TVC Imaging System™, which will be used to detect LRP in study participants.

Originally from Indianapolis, Muller has lived in Boston for 30 years and served as professor of medicine at Harvard Medical School. As a pre-medical student he started work at University of Notre Dame, learned Russian, and became an exchange student to Moscow in medical studies. As tensions ran high in the Cold War, he was one of the founders of International Physicians for Prevention of Nuclear War, the organization awarded the 1985 Nobel Peace Prize.

Today Muller credits the efforts of Dr. Andre Artis, interventional cardiologist at Methodist Hospitals in Gary and Merrillville, for his role in getting the study started with participants.

“Dr. Artis has been leading the way,” says Muller, enrolling more patients in this international study than any other facility with the exception of one large, university hospital. “It’s because of his leadership that the trial is going so well.” Artis, with expertise in placing stents in cardiac patients, seeks permission from his patients for them to be part of the Lipid-Rich Study, explaining its purpose, value, and process.

“As one of the nation’s leaders in cardiovascular medicine, Methodist Hospitals is proud to be involved in a cutting-edge research effort that could advance our understanding and management of coronary artery disease,” says Artis, who is also co-director of the Heart and Vascular Institute at Methodist Hospitals. “The findings from the LRP Study could show that patients with LRP are more prone to experiencing a major adverse cardiac event. That knowledge could help inform our decision of how and when to use drugs and/or interventional treatments like angioplasty to improve patient outcomes.”

‘I love what I do’

Kimberly Armstrong, coordinator of the study, works with Artis at Methodist’s Northlake campus at Gary, operating the Infraredx imaging device. “Our device, the TVC Insight™ Catheter. which detects cholesterol in the coronary arteries, is used in 120 hospitals,” The device uses both light and sound to examine the artery. Muller says. “It’s like eyes and ears for the doctor inside the heart, producing a picture like a fetus ultrasound picture. Without it, a patient can’t know how much and where the cholesterol is. The FDA says the device is the first device that detects lipid-rich plaques, which are of particular interest.”

After the imaging and when Artis has identified patients for the study, Armstrong enters patient data and obtains consenting and screening information. She explains to patients they need to be committed to participating for the two years the study is expected to last — but their only job is to respond to her follow-up calls, which determine whether the patient has had any adverse cardiac events during the study.

“I love what I do,” Armstrong says. “It’s very exciting to be a part of something that may be able to change how things are done to treat patients with heart disease.”

“I’ve led many scientific studies over the decades,” Muller says, “and the key to a successful study is a talented research coordinator, someone who’s dedicated to the study. (Armstrong) is such a skilled research nurse.”

Dr. Ron Waksman at Washington Hospital in Washington, D.C., is the principal investigator — independent of Infraredx — who led the development of the protocol for the study.

Muller says patients are enrolling in this study because they already have heart disease and “they want what we want: to prevent a second heart attack.”

“Right now we’re working to prevent a second heart attack. Once we succeed, we hope to become part of a strategy to prevent the first heart attack.”

Results of the two-year study are expected to be published in about two years, Muller says. For more information on the LRP Study visit http://clinicaltrials.gov/ct2/show/NCT02033694 or contact 884-9180.