‘FORTIFY’ Selects FAI-Score™ as Primary Outcome Measure, and Caristo as Worldwide Imaging Core Lab for Coronary Inflammation and Plaque Measurement and Monitoring
Caristo Diagnostics, on a mission to transform the diagnosis and treatment of cardiovascular disease, today, congratulates Abcentra for the successful dosing of the first patient in the FORTIFY clinical trial (https://clinicaltrials.gov/study/NCT06927739), and announces Caristo’s role as FORTIFY trial’s worldwide imaging core lab. For the FORTIFY clinical trial, Caristo oversees all coronary inflammation and plaque measurement and monitoring, as well as contributes to patient selection through its proprietary CaRi-Heart® and FAI-Scor™e technologies.
The FORTIFY clinical trial (Focused Orticumab Research for Treating Inflammation in Coronary Arteries; NCT06927739) is a multi-center, randomized, placebo-controlled, double-blind trial designed to evaluate the efficacy of orticumab in reducing local coronary inflammation in patients with a history of type 1 myocardial infarction (MI) and elevated coronary inflammation. A total of 240 adults with a history of type 1 MI and elevated Fat Attenuation Index (FAI) Score — determined using Caristo’s CaRi-Heart technology — are being enrolled at 40 sites in the U.S. and Europe.
Caristo’s core laboratory responsibilities for the FORTIFY trial include:
- Certifying and training each clinical site to ensure high-quality coronary computed tomographic angiography (CCTA) imaging
- Supporting patient enrollment by identifying eligible candidates based on elevated coronary inflammation as measured by FAI-Score, an AI-powered imaging biomarker that is an independent predictor of future major adverse cardiovascular events
- Conducting baseline and follow-up analyses for all randomized patients at 24 weeks
- Quantifying coronary inflammation using CaRi-Heart technology, which leverages the FAI-Score
- Providing comprehensive cardiovascular risk calculations, plaque analysis using CaRi-Plaque™, image quality control, and radiation dose optimization
“We chose Caristo because their cutting-edge imaging technology allows us to measure coronary inflammation with unprecedented precision,” said Christopher Farina, CEO of Abcentra. “This will be vital to confirming orticumab’s potential to address coronary inflammation, one of the root causes of heart attacks.”
“Pharma and biotech sponsors are increasingly turning to Caristo to help select trial candidates and evaluate how both coronary plaque and inflammation — two critical and independent predictors of heart attack risk — are affected by a trial drug,” said Frank Cheng, CEO of Caristo Diagnostics. “We are proud to partner with Abcentra on FORTIFY and to support their groundbreaking work in developing targeted anti-inflammatory therapies with FAI-Score chosen as the primary outcome endpoint.”
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