ELUCIDATE FFRct Study

February 15, 2024 updated by: Elucid Bioimaging Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Not yet recruiting
        • Cardiovascular Medical Group of Southern California
        • Contact:
          • Ronald P Karlsberg, MD
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Not yet recruiting
        • Piedmont Healthcare
        • Contact:
          • Venkateshwar Polsani, MD
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Not yet recruiting
        • Parkview Health
        • Contact:
          • Dustin Thomas, MD
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Midwest Heart and Vascular Specialists
        • Contact:
          • Stephen A Bloom, MD
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • Not yet recruiting
        • Valley Health System
        • Contact:
          • Himanshu Gupta, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
        • Contact:
          • Milind Desai, MD, MBA
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Centennial Heart
        • Contact:
          • David Huneycutt, MD
      • Nashville, Tennessee, United States, 37205
        • Not yet recruiting
        • Ascension Medical Group
        • Contact:
          • Andrew O Zurich, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
          • Patricia Rodriguez-Lozano, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults >=18 years with at least one 30-90% stenosis on CCTA (>64- detector row) performed within 60 days of undergoing invasive FFR.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low FFR
Invasive FFR <= 0.80
Device: ElucidVivo
Plaque morphology characterization on coronary CTA for predicting fractional flow reserve (FFRct)
High FFR
Invasive FFR > 0.80
Device: ElucidVivo
Plaque morphology characterization on coronary CTA for predicting fractional flow reserve (FFRct)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of FFRct versus invasive FFR for detecting invasive FFR ≤ 0.80
Time Frame: 1 day
Per-vessel
1 day
Specificity of FFRct versus invasive FFR for detecting invasive FFR ≤ 0.80
Time Frame: 1 day
Per-vessel
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of FFRct for detecting invasive FFR ≤ 0.80
Time Frame: 1 day
Per-patient
1 day
Specificity of FFRct for detecting invasive FFR ≤ 0.80
Time Frame: 1 day
Per-patient
1 day
Area under the receiver-operating characteristic curve (AUC) of FFRct for detecting invasive FFR ≤ 0.80
Time Frame: 1 day
Per-vessel
1 day
Area under the receiver-operating characteristic curve (AUC) of FFRct for detecting invasive FFR ≤ 0.80
Time Frame: 1 day
Per-patient
1 day
Accuracy of FFRct for detecting invasive FFR ≤ 0.80
Time Frame: 1 day
Per-vessel
1 day
Accuracy of FFRct for detecting invasive FFR ≤ 0.80
Time Frame: 1 day
Per-patient
1 day
Negative predictive value of FFRct for detecting invasive FFR ≤ 0.80
Time Frame: 1 day
Per-vessel
1 day
Negative predictive value of FFRct for detecting invasive FFR ≤ 0.80
Time Frame: 1 day
Per-patient
1 day
Positive predictive value of FFRct for detecting invasive FFR ≤ 0.80
Time Frame: 1 day
Per-vessel
1 day
Positive predictive value of FFRct for detecting invasive FFR ≤ 0.80
Time Frame: 1 day
Per-patient
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elucid Bioimaging Inc.

Collaborators

Lundquist Institute at Harbor-UCLA Medical Center

Investigators

  • Principal Investigator: Ziad Ali, MD, Catholic Health - St. Francis Hospital
  • Principal Investigator: Todd C Villines, MD, Elucid Bioimaging Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-ST-03-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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