Elucid Kicks Off Review of its Plaque Analysis Tool

Elucid has begun recruiting potential sites for its Plaque as a Risk Factor for Evaluation of Vascular Events (PRE-VUE) CT Registry Study. 
 
PRE-VUE is an international, multicenter, retrospective trial evaluating the prognostic accuracy of Elucid’s next generation, histology-defined plaque analysis, PlaqueIQ, and investigational plaque-based FFRCT software in predicting major cardiac adverse events (MACE) in patients who received clinically indicated coronary CT angiography (CCTA). The study will include at least 30 centers and a minimum 10,000-patient pool (ages 18 and older), all of whom underwent CCTA with continuous follow-up for at least 36 months.

The lead investigators for the study are Dr. Carlo De Cecco (Emory University, Atlanta) and Dr. Márton Kolossváry (Gottsegen National Cardiovascular Center, Budapest, Hungary).
 
“This registry will aim to provide world-wide physicians the most accurate information on coronary plaque to improve cardiovascular risk prediction and support the selection of patient-specific treatment,” De Cecco said. “The ultimate goal is to positively impact cardiovascular health globally with a reduction in cardiovascular events.”
 
Dr. Kolossváry added, “The PRE-VUE registry will empower us to see the true additive value of CT-derived, histologically validated plaque volumes in predicting future adverse cardiovascular events.” 
 
Cardiovascular disease is the most common cause of death and disability globally, largely driven by myocardial infarction and ischemic stroke caused by atherosclerosis (plaque build-up in the arteries).ⁱ Although plaque disruption is the most common cause of arterial thrombotic events,ⁱⁱ traditional diagnostic methods for characterizing plaque use subjective visual assessments, which vary according to scanning protocol or interpreter and can omit critical patient risk information such as identifying vulnerable plaque types.ⁱⁱⁱ
 
Elucid is addressing the need for new objective, non-invasive diagnostic methods that more accurately quantify and characterize plaque, including vulnerable plaques, based on actual histology (the microscopic structure of organic tissues excised from live patients). Elucid’s PlaqueIQ is the first and only histology-validated U.S. Food and Drug Administration-cleared software to non-invasively quantify and characterize non-calcified plaque and its components such as lipid-rich necrotic core (LRNC), giving potential insights into high-risk plaques, key drivers of risk of heart attack and stroke. The company is also pursuing an indication for non-invasive measurement of fractional flow reserve (FFRCT), uniquely derived from its plaque algorithm, to measure coronary blockages and the extent of ischemia.
 
“Characterizing anatomical and physiological parameters through the amount and type of plaque in a patient’s artery is essential to understanding their risk of heart attack and stroke. Elucid is committed to building a large repository of rigorous evidence to support our histology-based solutions, and the PRE-VUE trial is a testament to this,” Elucid Board Chairman Scott Huennekens said. “Building on the significant clinical study work we have done to date, this trial breaks new ground in our field, as it uniquely investigates a large and diverse patient population spread across a variety of international healthcare settings. We are grateful for the PRE-VUE investigators, who see great potential in our unique platform and non-invasive solutions that support clinical intervention decisions to halt and reverse trends in cardiovascular disease.” 
 
Elucid is a Boston-based AI medical technology company dedicated to developing technology designed to help physicians better understand the root cause of cardiovascular disease.  Elucid’s PlaqueIQ software is a computed tomography angiography (CTA) algorithm that objectively quantifies plaque morphology validated against ground truth histology. Elucid is also pursuing an indication for FFRCT, derived from its plaque algorithm, to help identify coronary blockages and the extent of ischemia non-invasively. PlaqueIQ equips physicians with critical information regarding the type and amount of plaque in arteries that can lead to heart attack and stroke. 
 
References 
ⁱ World Health Organization (WHO), Cardiovascular diseases (CVDs) fact sheet. 2017 23, April 2020]; Available from: https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds.
ⁱⁱ A. Hafiane, Vulnerable plaque, characteristics, detection, and potential therapies, J. Cardiovasc. Dev. Dis. 6 (3) (2019).
ⁱⁱⁱ https://www.nhlbi.nih.gov/health/atherosclerosis