Cleerly® ISCHEMIA™ Demonstrates Robust Diagnostic Accuracy and Prognostic Utility in Analyses from Large Scale Clinical Trials
29 March 2024 - 2:44AM
Business Wire
CREDENCE and PACIFIC-1 study data demonstrate
potential power of AI-QCT ISCHEMIA
Cleerly, the company on a mission to create a new standard of
care to aid in the diagnosis of heart disease, shared findings from
a study published online in the Journal of the American College of
Cardiology: Cardiovascular Imaging on March 13, 2024. The study
describes the validation of Cleerly's artificial
intelligence-guided quantitative coronary CT angiography (AI-QCT)
ISCHEMIA technology for diagnostic accuracy and prognostic risk
stratification.
In two trials,1-2 the CREDENCE and PACIFIC-1 studies comprised a
total of 513 patients who underwent coronary CT angiography,
myocardial perfusion imaging with single photon emission CT
(SPECT), and fractional flow reserve derived from CT (FFRCT). For
patients with an abnormal Cleerly AI-QCT ISCHEMIA finding, a
positive result was associated with an approximately 7-fold
increase of adverse cardiovascular events during an 8-year
follow-up. Collectively, this study shows that Cleerly AI-QCT
ISCHEMIA, when used in conjunction with Cleerly LABS, can provide a
3-in-1 approach for the assessment of atherosclerosis, stenosis and
ischemia.
"This pivotal study was performed in two different international
populations which shows that CCTA analyzed with the Cleerly AI-QCT
ISCHEMIA device provides an accurate assessment of coronary
ischemia,” said James P. Earls, MD, Chief Medical Officer of
Cleerly. “These promising findings offer the possibility of a novel
care paradigm for symptomatic coronary artery disease evaluation
that performs comprehensive analysis of atherosclerosis, stenosis
and ischemia from a single non-invasive CCTA test, which may offer
the benefit of guiding clinical decision making for both coronary
revascularization and medical therapy."
These study results come after Cleerly announced that its
Cleerly ISCHEMIA software device is billable using the new Category
I CPT® code 75580.
About Cleerly®
Cleerly is the company on a mission to eliminate heart attacks
by creating a new standard of care for heart disease. Through its
FDA-cleared solutions driven by artificial intelligence, Cleerly
supports comprehensive phenotyping of coronary artery disease, as
determined from advanced non-invasive CT imaging. Cleerly’s
approach is grounded in science, based on over 10 million images
from over 40,000 patients gathered over a 15-year-period in
landmark, multi-center clinical trials. Led by a world-class
clinical and technical team, Cleerly enhances health literacy for
each and every stakeholder in the coronary care pathway. For more
information, please visit: www.cleerlyhealth.com.
Disclaimer:
Cleerly ISCHEMIA is an add-on software module to Cleerly Labs
that determines the likely presence or absence of coronary vessel
ischemia, with the thresholds equivalent to invasive FFR ≤0.80 vs.
>0.80, respectively. This threshold was chosen in accordance
with the American Heart Association / American College of
Cardiology professional societal guidelines that advocate for the
use of FFR ranges at the 0.80 level to be used to guide clinical
decision making for determining appropriateness of coronary
revascularization.3 The diagnostic performance of Cleerly ISCHEMIA
for non-invasive determination of the functional significance of
CAD has been validated against direct invasive measurement of
FFR.2
Cleerly ISCHEMIA prediction is based on coronary lesion
morphology and plaque characteristics from CCTA imaging. It is a
clinical decision support tool that should be used with the
entirety of relevant patient specific data when making a diagnosis
or clinical decision.
References:
- Nurmohamed NS, Danad I, Jukema RA, et al. High Diagnostic
Accuracy of AI-ISCHEMIA in Comparison to PET, FFR-CT, SPECT, and
Invasive FFR: A Pacific Substudy.. J Am Coll Cardiol. 2023 Mar, 81
(8_Supplement) 1362.
- Nurmohamed NS, Danad I, Jukema RA, et al. Development and
Validation of a Quantitative Coronary CT Angiography Model for
Diagnosis of Vessel-Specific Coronary Ischemia. JACC Cardiovasc
Imaging. 2024 Feb 29:S1936-878X(24)00039-1. doi:
10.1016/j.jcmg.2024.01.007. Epub ahead of print. PMID:
38483420.
- Gulati M, Levy PD, Mukherjee D, et al. 2021
AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and
Diagnosis of Chest Pain: A Report of the American College of
Cardiology/American Heart Association Joint Committee on Clinical
Practice Guidelines. Circulation. 2021 Nov
30;144(22):e368-e454.
Disclosures:
This study was sponsored by Cleerly, Inc. and journal article
authors Hao Wang, MS; Chung Chan, PhD; Tami Crabtree, MS; Melissa
Aquino, MS; James K. Min, MD; and James P. Earls, MD are employees
of Cleerly, Inc.
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