Dr. Amir Lotfi of the Division of Cardiology and Heart & Vascular Services will serve as the national co-primary investigator (PI) of a new clinical trial of using supersaturated oxygen in patients who have experienced a heart attack.
What is the clinical trial for and how will it work?
Sponsored by ZOLL Circulation, Inc., USA, AMIHOT III Supersaturated Oxygen Delivery in Anterior MI Patients will randomize heart attack patients in the hospital to receive either PCI or PCI followed by 60 minutes of supersaturated oxygen delivery to see if it helps lessen damage to their heart muscle. (PCI = percutaneous coronary intervention, angioplasty with a stent. This method uses a catheter to hold open blood vessels in the heart that have been narrowed by plaque buildup.)
The study hopes to start in spring 2022 at Baystate.
Baystate previously participated in the IC-HOT trial, which studied the technology behind supersaturated oxygen, a few years ago. The FDA has approved the supersaturated oxygen technology from this trial.
What prompted the AMIHOT III study?
“We have become very good at opening up the blood vessels in the heart [to allow more blood flow], and our goal is [to do so] less than 90 minutes,” explained Dr. Lotfi. “But one thing we have noticed is that when we open the blood vessels, there’s a risk of increased heart tissue damage called reperfusion injury.”
What is reperfusion injury?
When blood vessels are opened too suddenly, a gush of blood may activate a negative effect on the heart muscle, which can cause irregular heartbeat and/or possible lifelong damage to the heart muscle. Many people have been working on a better way to protect the heart to help reduce incidents like this. There are ongoing studies and have been multiple prior studies using different technologies to see if they can help prevent heart tissue injury.
AMIHOT III uses supersaturated oxygen in the largest blood vessel in the heart (the left anterior descending coronary artery).
How does oxygen get “supersaturated”?
“Blood is taken from the body and infused with a high saturation of oxygen using a special console,” said Dr. Lotfi. “This is using the technology previously approved in the IC-HOT study. From there, it is re-infused to the blood vessel of the heart.”
A national and international study
In addition to serving as local site PI at Baystate, Dr. Lofti joined as national co-principal investigator by Dr. James Blankenship of the University of New Mexico. The study is currently in the U.S. and Canada and hopes to move internationally to Europe.
“The biggest goal is to see if this therapy leads to less muscle damage and better outcomes,” concluded Dr. Lotfi.
ClinicalTrials.gov Identifier: NCT04743245