Patients who suffer from severe heart attacks may find their source of future heart protection in lakes and ponds, new research suggests.
Clinical researchers at Stony Brook Medicine’s Heart Institute are part of the PRESERVATION clinical trial, a study to evaluate the safety and effectiveness of bioabsorable cardiac matrix (BCM) in preventing further heart failure in patients who have suffered a large heart attack with significant damage to the muscle. BCM is a substance partially made of algae.
Stony Brook has three patients enrolled so far and is one of 15 centers participating in the international research. Phase 2 of the study, which began at least two years ago, has 292 patients but needs 14 more.
A patient is enrolled after he or she has suffered a massive heart attack. To treat the heart attack, doctors open the blocked coronary artery, take the clot out, insert balloons and stents so the artery is open and blood flow can return to normal. Two to four days later, if the patient qualifies and agrees to participate, he or she is assessed to ensure that the artery is still open, and doctors directly inject the BCM substance into the artery closed at the time of the heart attack.
“These are the patients at high risk … what happens when you have a heart attack [is] it creates permanent damage to muscles of the heart,” Dr. Luis Gruberg, Stony Brook’s director of research in interventional cardiology, told FoxNews.com. “They will develop heart failure, which has bad outcomes in the long-term.”
After a large heart attack, the damaged scar tissue of the heart bulges out, making the organ inefficient. In these cases, blood moves outward rather than contracting inward, which can result in heart failure. When the substance is injected and comes into contact with calcium, it forms a matrix that prevents the heart from “remodeling,” Gruberg said.
“What we’re doing is taking the part with significant damage to the muscle in the heart; we want to see if it helps them because those are patients that need the most help,” Gruberg said.
Following the injection, the matrix slowly disappears and absorbs into the body in about two to four months, the time it takes for the heart to repair.
“The heart is in a very vulnerable position immediately after a heart attack; it needs some time to repair itself,” Gruberg said. “The idea is that this device helps the heart withstand the pressure created inside the ventricle.”
Three months after initial enrollment, researchers reassess patients’ heart function and will follow up with them for three years.
Gruberg said it’s too soon to determine whether the device has restored normal heart function. He also noted that it’s difficult to enroll patients because many are being treated aggressively at the beginning, therefore very few develop quickened heart failure.
Gruberg said he hoped to complete enrollment within the next month. That way, researchers would be able to analyze the results in two to three years, after which they can conduct a randomized third phase of the study with a larger population.
About 60 percent of patients who have a heart attack will have reduced function of the heart muscle; 40 percent of those will go on and develop heart failure symptoms, Gruberg said. Once a person is diagnosed with heart failure, he or she has a high mortality rate— about 25 percent may die in the first year, and 50 percent in five years.
“As the population gets older, we’re seeing more and more of these things, unfortunately,” Gruberg said.