Hendrick Health enrolling patients for cardiovascular disease clinical trial

Hendrick Health is currently enrolling participants for a clinical trial (TRANSFORM) that compares a stage-based treatment of patients with coronary artery disease or who are at risk of atherosclerotic cardiovascular disease based on a CCTA exam, with a risk-factored based treatment, which is the standard of care. Hendrick is one of 47 sites conducting this research across the United States, Europe and Japan.

Patients accepted into this randomized clinical trial, will undergo a coronary computer tomography angiography (CCTA) exam to categorize the patient’s atherosclerosis severity. The results of the CCTA will be used to randomize the patients into the type of treatment they receive.

“The TRANSFORM trial will fundamentally change our understanding of the development of coronary artery disease and how it responds to medical treatments,” said Dr. Ren Zhang, cardiologist at Hendrick Health and principal investigator for the Hendrick study site. “It is the first large scale study using AI technology to be able to visualize and quantify plaque burden for patients with coronary artery disease and its progression. With its AI technology, we will be able to visualize how medical therapies and interventions change or improve atherosclerosis of coronary arteries, and improve not only patients’ lives, but also the quality of their lives.”

This clinical trial program will have a sponsor that assists in coordinating the care and treatment approach with the research and cardiology teams at Hendrick. This provides patients with education of this trial and treatments, medical therapy and other study support.

For a patient to qualify, they must be:

• Men over the age of 55 with type 2 diabetes mellitus, prediabetes or metabolic syndrome and no known symptomatic cardiovascular disease
• Women over the age of 65 with type 2 diabetes mellitus, prediabetes or metabolic syndrome and no known symptomatic cardiovascular disease
• Patients must have a reliable device for communication with the cardiologist-led team managing their treatment

Because monitoring is a vital part of the study, patients will be followed for up to five years.

“The trial has potential to change the guidelines for how we diagnose coronary artery disease at earlier stages and treat the patient with more precise therapy,” said Zhang.

For enrollment eligibility, individuals should contact Hendrick Center for Research at research@hendrickhealth.org or 325-670-7724.