Evaluating a new software for assessing coronary artery disease
The ELUCIDATE FFRct Study
This study is testing a new software that looks at heart artery blockages to see if it can better help doctors understand heart problems in patients with coronary artery disease compared to standard methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elucid Bioimaging Inc. Industry-sponsored |
| Locations | 9 sites (Beverly Hills, California and 8 other locations) |
| Trial ID | NCT06018194 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the diagnostic accuracy of a novel plaque-based coronary CT angiography (CCTA) fractional flow reserve (FFRct) software device. Researchers will compare the Elucid plaque-based FFRct analysis to invasively measured FFR in patients who have undergone both CCTA and invasive FFR. The study focuses on understanding how plaque burden and composition can improve the estimation of ischemia compared to traditional methods. By utilizing advanced imaging and deep-learning models, the study seeks to enhance clinical decision-making for patients with coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with at least one 30-90% stenosis on CCTA performed within 60 days of invasive FFR.
Not a fit: Patients with a history of coronary revascularization, myocardial infarction, or certain heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate non-invasive method for assessing coronary artery disease, potentially leading to better patient outcomes.
How similar studies have performed: Preliminary studies have shown success with similar approaches, indicating potential for this novel method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Adults \>=18 years with at least one 30-90% stenosis on CCTA (\>64- detector row) performed within 60 days of undergoing invasive FFR. Exclusion Criteria: * History of coronary revascularization with coronary artery bypass graft (CABG) surgery and/or percutaneous coronary intervention (PCI) (stent or balloon angioplasty) prior to CCTA and invasive FFR. * History of myocardial infarction prior to CCTA and invasive FFR. * Known complex congenital heart disease. * Existing pacemaker or internal defibrillator lead implantation(s). * Existing prosthetic heart valve. * Absence of CCTA Digital Imaging and Communications in Medicine (DICOM) data for analysis. * Absence of invasive coronary angiography imaging or adequate description defining the position of the invasive FFR wire location. * Poor CCTA image quality that does not meet Elucid image processing requirements for plaque and FFRct. * Absence of study date for CCTA or invasive FFR. * Interval clinical myocardial infarction, diagnosis of decompensated heart failure, stroke, or coronary revascularization procedure between CCTA and invasive FFR. * Non-diagnostic CCTA or invasive FFR. Studies where the results of the study were deemed non-diagnostic for clinical decision-making will be excluded. * CCTA or invasive FFR studies performed prior to 1 January 2016.
Where this trial is running
Beverly Hills, California and 8 other locations
- Cardiovascular Medical Group of Southern California — Beverly Hills, California, United States (Not_yet_recruiting)
- Piedmont Healthcare — Atlanta, Georgia, United States (Not_yet_recruiting)
- Parkview Health — Fort Wayne, Indiana, United States (Not_yet_recruiting)
- Midwest Heart and Vascular Specialists — Overland Park, Kansas, United States (Recruiting)
- Valley Health System — Ridgewood, New Jersey, United States (Not_yet_recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Not_yet_recruiting)
- Centennial Heart — Nashville, Tennessee, United States (Not_yet_recruiting)
- Ascension Medical Group — Nashville, Tennessee, United States (Not_yet_recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Ziad Ali, MD — Catholic Health - St. Francis Hospital
- Study coordinator: Todd C Villines, MD
- Email: todd.villines@elucid.com
- Phone: 978-468-0508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.