#United States #Stamford #Caristo Diagnostics #cardiovascular study #REMBRANDT trial

Caristo Diagnostics Takes Center Stage in Revolutionary Cardiovascular Study

Caristo Diagnostics, a pioneering firm in cardiovascular disease diagnostics, has taken a monumental step in the realm of heart health by being chosen as the global imaging core lab for NewAmsterdam Pharma’s significant REMBRANDT clinical trial. This collaboration marks an essential development in modern healthcare's approach to understanding coronary plaque and inflammation.

What is the REMBRANDT Trial?

The REMBRANDT trial is a double-blind, placebo-controlled study aimed to evaluate the efficacy of a combination of obicetrapib, an investigational cholesteryl ester transfer protein (CETP) inhibitor, and ezetimibe on reducing coronary plaque burden. This innovative treatment approach holds potential for decreasing low-density lipoprotein cholesterol (LDL-C), with earlier trials showcasing promising results. Specifically, it targets non-calcified coronary atherosclerotic plaque volume (NCPV), which could signify improved outcomes for patients facing atherosclerotic cardiovascular disease (ASCVD).

Objectives of the Trial

Caristo Diagnostics’ role will be pivotal, overseeing coronary plaque assessments across approximately 50 clinical sites in seven countries, including the United States, Poland, United Kingdom, Czech Republic, Hungary, Italy, and Spain. The primary goal is to track the percentage change in total NCPV from baseline to 18 months, assessed via coronary computed tomographic angiography (CCTA). In addition to measuring plaque burden, the trial will also monitor coronary inflammation using Caristo's proprietary FAI-Score™, which serves as a critical indicator of ASCVD risk.

Caristo’s Responsibilities

As the imaging core lab, Caristo is tasked with several essential functions:

• - Training and certifying each clinical site to ensure the consistent quality of CCTA imaging.
• - Conducting baseline and follow-up analyses for all randomized patients at 6 and 18 months.
• - Measuring plaque burden, assessing coronary inflammation with FAI-Score, and compiling thorough cardiovascular risk evaluations.
• - Maintaining strict image quality control, ensuring proper data anonymity, and managing radiation exposure effectively.

CEO Frank Cheng expressed pride in Caristo's significant role within this groundbreaking trial, emphasizing an increasing recognition from both pharmaceutical and biotech sponsors of Caristo’s capabilities in evaluating new drug impacts on coronary health.

Expert Insights

Dr. Cheerag Shirodaria, an Honorary Consultant Cardiologist, remarked on the recent advances in imaging technology, which yield vital insights into medications' mechanisms of action. The detailed information from the REMBRANDT trial is expected to significantly assist clinicians in understanding the implications of obicetrapib on coronary plaque morphology.

Professor John Kastelein, Co-Founder and Chief Scientific Officer at NewAmsterdam Pharma, expressed enthusiasm for working alongside Caristo, viewing this partnership as integral to their clinical development strategy focus.

About Caristo Diagnostics

Founded as a spin-out from the University of Oxford, Caristo Diagnostics stands as a leader in heart disease diagnostics, dedicated to transforming cardiovascular care. Their award-winning technologies significantly improve the early detection of heart attack risks, emphasizing the importance of personalized prevention strategies. Collaborating with leading healthcare institutions and scientists worldwide, Caristo is on a mission to save lives by enabling early diagnosis and tailored interventions. For detailed information, visit caristo.com.

This partnership reflects a broader trend in healthcare, where leveraging advanced imaging technologies can lead to groundbreaking developments in treatment and diagnosis, particularly for cardiovascular diseases, which remain one of the leading health challenges globally.