Elucid Commences International PRE-VUE CCT Registry Study
18 Julio 2024 - 6:05AM
Business Wire
Multi-center, Retrospective Trial to Assess
Prognostic Accuracy of Elucid’s Plaque and Plaque-based FFRCT
Software in Patients with Clinically Indicated CCTA
SCCT2024 – Elucid, a pioneering AI medical technology
company providing physicians with imaging analysis software based
on ground truth histology to support diagnosis and treatment of
cardiovascular disease, has initiated site recruitment for its
Plaque as a Risk Factor for Evaluation of Vascular Events (PRE-VUE) CT Registry Study. The lead
investigators for the study are Dr. Carlo De Cecco (Emory
University, Atlanta) and Dr. Márton Kolossváry (Gottsegen National
Cardiovascular Center, Budapest, Hungary).
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 adverse cardiac
events (MACE) in patients who have received clinically indicated
coronary CT angiography (CCTA). The study will include at least 30
centers 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 Dr. De Cecco. “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).1 Although plaque disruption, such as rupture, is the
most common cause of arterial thrombotic events,2 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.3,2
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 FDA-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,” 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.”
About Elucid
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 the only FDA-cleared computed tomography
angiography (CTA) algorithm that objectively quantifies plaque
morphology validated against ground truth histology, the gold
standard for characterization of coronary plaques, as indicated by
renowned pathologists. 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. For more information, visit elucid.com.
____________________
1
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).
2
A. Hafiane, Vulnerable plaque,
characteristics, detection, and potential therapies, J. Cardiovasc.
Dev. Dis. 6 (3) (2019).
3
https://www.nhlbi.nih.gov/health/atherosclerosis
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Media Contact: Sam Choinski Pazanga Health Communications
(860) 301-5058 schoinski@pazangahealth.com