March 6, 2025
Holy Name today announced its participation in the TRANSFORM trial, a groundbreaking clinical study designed to evaluate investigational personalized care strategies for the prevention of heart attacks, strokes, and other serious heart-related issues. This pivotal study will compare two approaches, over the course of 2-5 years, to prevent heart disease in 7,500 participants who have underlying conditions, including type 2 diabetes, pre-diabetes, high cholesterol, or metabolic syndrome and no symptoms or history of heart disease.
At Holy Name, the TRANSFORM trial will enroll men aged 55 and older and women aged 65 and older, providing an opportunity to evaluate potential approaches to heart disease prevention among this age group.
At Holy Name, principal investigators Dr. Jaffar Raza, an interventional cardiologist, and Dr. Jeffrey Goldman, radiologist, will lead the study to assess whether pairing coronary CT angiography (CCTA) with an artificial intelligence (AI) platform is superior to the standard methods of care in detecting coronary artery plaque buildup.
At Holy Name, the physicians will utilize Photon-counting CT (PCCT), a revolutionary new technology where the X-ray photons can be directly converted to electrical signals. By comparison, with traditional CT technology, X-rays are converted to light and then to electric signals in a two-step process. This single step process of PCCT decreases noise and increases spatial resolution while decreasing radiation dose. Holy Name is among the few hospitals worldwide, and one of only two in Northern New Jersey, offering PCCT technology for cardiac imaging.
"We are proud to bring this landmark study to our community," says Dr. Raza. "The findings could have significant implications for how we approach heart disease treatment and prevention. By comparing two care methods, we hope to learn whether a tailored, real-time imaging approach may more effectively reduce cardiovascular events than the traditional method that focuses mainly on risk factors. The results of this study could reshape how we prevent and treat heart disease."
Participants will be randomly assigned to one of two care strategies: investigational personalized care or traditional care. All participants will undergo coronary CT angiography (CCTA) at Holy Name at the start of the trial and again at the 2-year mark. In patients randomized to the personalized care arm, results will be reviewed by a central cardiologist-led team for discussion and care planning. Patients receiving traditional care will be treated based on atherosclerotic cardiovascular disease (ASCVD) risk factors, while those in the personalized care strategy will review an investigational coronary artery disease (CAD) plaque staging system report with a cardiologist and be treated based on the results.
By participating in the TRANSFORM trial, individuals contribute to research that could lead to potentially life-saving discoveries. With advanced technologies and a collaborative team of experts, the TRANSFORM study could advance our understanding of how to prevent heart disease and improve outcomes for millions of people at risk.
Individuals interested in learning more about the TRANSFORM study or determining eligibility can visit the Institute for Clinical Research at Holy Name or contact [email protected].