Coronary Artery DiseaseNCT06018194
ELUCIDATE FFRct Study
An observational study of Coronary Artery Disease, run by Elucid Bioimaging Inc. at 8 sites in United States.
Trial summary
The goal of this study is to evaluate the diagnostic accuracy of a novel plaque-based coronary CT angiography (CCTA) fractional flow reserve (FFRct) software device for the estimation of invasive fractional flow reserve (FFR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- ElucidVivo
- Type of treatment
- Medical device
- How many people
- 439 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Sep 2023to 28 Jul 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults >18 years with CCTA (>64-detector row) performed within 60 days of undergoing invasive FFR.
Who may be able to join
- 1. Adults >18 years with 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.
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- 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 (See Image Analysis Manual below).
- 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 were excluded.
- CCTA or invasive FFR studies performed prior to 1 January 2012.
- Subjects who had IFR or CFR and not measured FFR.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Piedmont Healthcare
Atlanta, Georgia, 30309
Cardiovascular Medical Group of Southern California
Beverly Hills, California, 90210
University of Virginia
Charlottesville, Virginia, 22908
Parkview Health
Fort Wayne, Indiana, 46845
Ascension Medical Group
Nashville, Tennessee, 37205
Mount Sinai Morningside
New York, New York, 10025
Midwest Heart and Vascular Specialists
Overland Park, Kansas, 66211
Valley Health System
Ridgewood, New Jersey, 07450
About this study
Official title: The ELUCIDATE FFRct Study
The goal of this study is to evaluate the diagnostic accuracy of a novel plaque-based coronary CT angiography (CCTA) fractional flow reserve (FFRct) software device for the estimation of invasive fractional flow reserve (FFR).
Researchers will compare the Elucid plaque-based FFRct analysis to invasively measured FFR in patients who have previously undergone CCTA and invasively assessed FFR.
Read the detailed description
Invasive fractional flow reserve is a clinically validated measure of lesion-specific ischemia and is preferred over visual estimation of diameter stenosis for clinical decision-making regarding coronary revascularization in patients with stable clinical presentations. Fractional flow reserve derived from coronary computed tomography angiography (FFRct) using computational fluid dynamic (CFD)-based software has been shown to be a reasonably accurate estimate of invasive FFR and is included in contemporary guidelines as a decision-tool for management of patients with intermediate stenosis on CCTA. However, CFD-based FFRct is calculated based predominately on detailed coronary lumen geometry. It is understood that the burden and type of coronary atherosclerosis, in addition to lumen geometry, significantly impacts the vasodilatory capacity of the coronary endothelium.
Preliminary studies suggest that invasive FFR can be accurately estimated based on the quantification of coronary plaque burden and the assessment of plaque composition. Previously, the investigators have demonstrated that a novel plaque-based FFRct approach, using a histologically validated software (ElucidVivoTM) for the measurement of plaque morphology (volume, plaque risk characteristics, and stenosis) to train a deep-learning model, was shown to be accurate and superior to lumen stenosis for predicting invasive FFR in a single-site feasibility study.
In this study, the investigators seek to assess the diagnostic accuracy of the Elucid plaque-based FFRct software to estimate invasive FFR in patients at multiple centers.
- Conditions
- Coronary Artery Disease
- Being tested
- ElucidVivo
- Keywords
- coronary computed tomographic angiography, coronary CTA, cardiac CT, fractional flow reserve, plaque
- Medical subject headings
- Coronary Artery Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElucidVivoDevice
Plaque morphology characterization on coronary CTA for predicting fractional flow reserve (FFRct)
| Study group | Role | What they receive |
|---|---|---|
| Low FFR | Invasive FFR <= 0.80 Receives: Device: ElucidVivo | |
| High FFR | Invasive FFR > 0.80 Receives: Device: ElucidVivo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of FFRct versus invasive FFR for detecting invasive FFR ≤ 0.80
Per-vessel
Measured: 1 day
Specificity of FFRct versus invasive FFR for detecting invasive FFR ≤ 0.80
Per-vessel
Measured: 1 day
Secondary outcomes (10)
Sensitivity of FFRct for detecting invasive FFR ≤ 0.80
Per-patient
Measured: 1 day
Specificity of FFRct for detecting invasive FFR ≤ 0.80
Per-patient
Measured: 1 day
Area under the receiver-operating characteristic curve (AUC) of FFRct for detecting invasive FFR ≤ 0.80
Per-vessel
Measured: 1 day
Area under the receiver-operating characteristic curve (AUC) of FFRct for detecting invasive FFR ≤ 0.80
Per-patient
Measured: 1 day
Accuracy of FFRct for detecting invasive FFR ≤ 0.80
Per-vessel
Measured: 1 day
Accuracy of FFRct for detecting invasive FFR ≤ 0.80
Per-patient
Measured: 1 day
Negative predictive value of FFRct for detecting invasive FFR ≤ 0.80
Per-vessel
Measured: 1 day
Negative predictive value of FFRct for detecting invasive FFR ≤ 0.80
Per-patient
Measured: 1 day
Positive predictive value of FFRct for detecting invasive FFR ≤ 0.80
Per-vessel
Measured: 1 day
Positive predictive value of FFRct for detecting invasive FFR ≤ 0.80
Per-patient
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Sep 2023
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elucid Bioimaging Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ziad Ali, MD, Principal investigator, Catholic Health - St. Francis HospitalOmar Khalique, MD, Principal investigator, Catholic Health- St. Francis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018194
- Sponsor's protocol ID
- 200-REC-003
- Status last verified
- Sep 2026
- First submitted
- 23 Aug 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 Jan 18;145(3):e4-e17. doi: 10.1161/CIR.0000000000001039. Epub 2021 Dec 9.
PubMed 34882436Gulati M, Levy PD, Mukherjee D, Amsterdam E, Bhatt DL, Birtcher KK, Blankstein R, Boyd J, Bullock-Palmer RP, Conejo T, Diercks DB, Gentile F, Greenwood JP, Hess EP, Hollenberg SM, Jaber WA, Jneid H, Joglar JA, Morrow DA, O'Connor RE, Ross MA, Shaw LJ. 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. doi: 10.1161/CIR.0000000000001029. Epub 2021 Oct 28.
PubMed 34709879Tesche C, De Cecco CN, Caruso D, Baumann S, Renker M, Mangold S, Dyer KT, Varga-Szemes A, Baquet M, Jochheim D, Ebersberger U, Bayer RR 2nd, Hoffmann E, Steinberg DH, Schoepf UJ. Coronary CT angiography derived morphological and functional quantitative plaque markers correlated with invasive fractional flow reserve for detecting hemodynamically significant stenosis. J Cardiovasc Comput Tomogr. 2016 May-Jun;10(3):199-206. doi: 10.1016/j.jcct.2016.03.002. Epub 2016 Mar 10.
PubMed 26993434Ahmadi A, Stone GW, Leipsic J, Serruys PW, Shaw L, Hecht H, Wong G, Norgaard BL, O'Gara PT, Chandrashekhar Y, Narula J. Association of Coronary Stenosis and Plaque Morphology With Fractional Flow Reserve and Outcomes. JAMA Cardiol. 2016 Jun 1;1(3):350-7. doi: 10.1001/jamacardio.2016.0263.
PubMed 27438119Diaz-Zamudio M, Dey D, Schuhbaeck A, Nakazato R, Gransar H, Slomka PJ, Narula J, Berman DS, Achenbach S, Min JK, Doh JH, Koo BK. Automated Quantitative Plaque Burden from Coronary CT Angiography Noninvasively Predicts Hemodynamic Significance by using Fractional Flow Reserve in Intermediate Coronary Lesions. Radiology. 2015 Aug;276(2):408-15. doi: 10.1148/radiol.2015141648. Epub 2015 Apr 17.
PubMed 25897475Varga-Szemes A, Schoepf UJ, Maurovich-Horvat P, Wang R, Xu L, Dargis DM, Emrich T, Buckler AJ. Coronary plaque assessment of Vasodilative capacity by CT angiography effectively estimates fractional flow reserve. Int J Cardiol. 2021 May 15;331:307-315. doi: 10.1016/j.ijcard.2021.01.040. Epub 2021 Jan 30.
PubMed 33529657Stuijfzand WJ, van Rosendael AR, Lin FY, Chang HJ, van den Hoogen IJ, Gianni U, Choi JH, Doh JH, Her AY, Koo BK, Nam CW, Park HB, Shin SH, Cole J, Gimelli A, Khan MA, Lu B, Gao Y, Nabi F, Nakazato R, Schoepf UJ, Driessen RS, Bom MJ, Thompson R, Jang JJ, Ridner M, Rowan C, Avelar E, Genereux P, Knaapen P, de Waard GA, Pontone G, Andreini D, Al-Mallah MH, Lu Y, Berman DS, Narula J, Min JK, Bax JJ, Shaw LJ; CREDENCE Investigators. Stress Myocardial Perfusion Imaging vs Coronary Computed Tomographic Angiography for Diagnosis of Invasive Vessel-Specific Coronary Physiology: Predictive Modeling Results From the Computed Tomographic Evaluation of Atherosclerotic Determinants of Myocardial Ischemia (CREDENCE) Trial. JAMA Cardiol. 2020 Dec 1;5(12):1338-1348. doi: 10.1001/jamacardio.2020.3409.
PubMed 32822476Lin A, van Diemen PA, Motwani M, McElhinney P, Otaki Y, Han D, Kwan A, Tzolos E, Klein E, Kuronuma K, Grodecki K, Shou B, Rios R, Manral N, Cadet S, Danad I, Driessen RS, Berman DS, Norgaard BL, Slomka PJ, Knaapen P, Dey D. Machine Learning From Quantitative Coronary Computed Tomography Angiography Predicts Fractional Flow Reserve-Defined Ischemia and Impaired Myocardial Blood Flow. Circ Cardiovasc Imaging. 2022 Oct;15(10):e014369. doi: 10.1161/CIRCIMAGING.122.014369. Epub 2022 Oct 13.
PubMed 36252116Buckler AJ, Sakamoto A, Pierre SS, Virmani R, Budoff MJ. Virtual pathology: Reaching higher standards for noninvasive CTA tissue characterization capability by using histology as a truth standard. Eur J Radiol. 2023 Feb;159:110686. doi: 10.1016/j.ejrad.2022.110686. Epub 2022 Dec 31.
PubMed 36603478