icole Kwan reports for FOXNews.com that clinical researchers at Stony Brook Medicine’s Heart Institute, in Stony Brook, NY, are part of the “Preservation” clinical trial, a study to evaluate the safety and effectiveness of bioabsorbable cardiac matrix (BCM) in preventing further heart failure in patients who have suffered a major heart attack with significant damage to the muscle.
The main component of BCM in its liquid form is a highly purified and stabilized form of alginate, the anionic polysaccharide present in purified brown algae. Alginate commonly is used as bone filler in orthopedic procedures and as an ingredient in various food products. It is safe and well accepted for consumption and internal administration.
Ikaria, Inc., a company focused on developing and commercializing innovative therapies for critically ill patients, produces BCM, formerly known as IK-5001. It is an aqueous liquid polymer mixture of sodium alginate and calcium gluconate, administered via injection directly into the coronary artery, intended to prevent the steps leading to heart failure in patients who recently have had a severe acute myocardial infarction (AMI).
When administered, BCM is designed to undergo a chemical and physical transformation to form an extracellular gel-like matrix that functions as a mechanical scaffold to provide support to the damaged heart muscle as it heals, thereby minimizing the changes in cardiac structure and function that can lead to CHF. Following several weeks, the matrix gradually dissipates and is naturally excreted by the kidneys as elevated calcium levels in the heart following AMI return to normal.
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 over two years ago, has 292 patients.
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.
“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.