RECRUITING
I'm interested ...!!
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.
Conditions:
🦠 Coronary Artery Disease
🗓️ Study Start (Actual) 1 September 2023
🗓️ Primary Completion (Estimated) 31 July 2024
✅ Study Completion (Estimated) 31 July 2024
👥 Enrollment (Estimated) 350
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Beverly Hills, California, United States
📍 Atlanta, Georgia, United States
📍 Fort Wayne, Indiana, United States
📍 Overland Park, Kansas, United States
📍 Ridgewood, New Jersey, United States
📍 Cleveland, Ohio, United States
📍 Nashville, Tennessee, United States
📍 Nashville, Tennessee, United States
📍 Charlottesville, Virginia, United States
More locations available...

📋 Eligibility Criteria

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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 23 August 2023
  • First Submitted that Met QC Criteria 28 August 2023
  • First Posted 30 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 February 2024
  • Last Update Posted 20 February 2024
  • Last Verified February 2024
I'm interested ...!!