Elucid has initiated site recruitment for its PRE-VUE CT registry study.
The study is an international, multicentre, retrospective trial evaluating the prognostic accuracy of Elucid’s histology-defined plaque analysis, PlaqueIQ, and investigational plaque-based FFRCT—fractional flow reserve derived from computed tomography (CT)—software in predicting major adverse cardiac events (MACE) in patients who have received clinically indicated coronary CT angiography (CCTA).
The lead investigators for the study are Carlo De Cecco (Emory University, Atlanta, USA) and Márton Kolossváry (Gottsegen National Cardiovascular Center, Budapest, Hungary).
The study will include at least 30 centres and a pool of at least 10,000 patients ages 18 and over, all of whom underwent CCTA with continuous follow-up for a minimum 36 months.
“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,” said De Cecco. “The ultimate goal is to positively impact cardiovascular health globally with a reduction in cardiovascular events.”
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.”
Elucid’s PlaqueIQ is a histology-validated US Food Administration (FDA)-cleared software to non-invasively quantify and characterise 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 FFRCT, uniquely derived from its plaque algorithm, to measure coronary blockages and the extent of ischaemia.
“Characterising 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,” said Scott Huennekens, executive chairman of the board, Elucid. “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.”
