ELUCIDATE FFRct Study

Description

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

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Study Overview

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Study Details

Study overview

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.

The ELUCIDATE FFRct Study

ELUCIDATE FFRct Study

Condition
Coronary Artery Disease
Intervention / Treatment

-

Contacts and Locations

Beverly Hills

Cardiovascular Medical Group of Southern California, Beverly Hills, California, United States, 90210

Atlanta

Piedmont Healthcare, Atlanta, Georgia, United States, 30309

Fort Wayne

Parkview Health, Fort Wayne, Indiana, United States, 46845

Overland Park

Midwest Heart and Vascular Specialists, Overland Park, Kansas, United States, 66211

Ridgewood

Valley Health System, Ridgewood, New Jersey, United States, 07450

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Nashville

Centennial Heart, Nashville, Tennessee, United States, 37203

Nashville

Ascension Medical Group, Nashville, Tennessee, United States, 37205

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22908

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Elucid Bioimaging Inc.,

Ziad Ali, MD, PRINCIPAL_INVESTIGATOR, Catholic Health - St. Francis Hospital

Todd C Villines, MD, PRINCIPAL_INVESTIGATOR, Elucid Bioimaging Inc.

Study Record Dates

2024-07-31