RECRUITING

ELUCIDATE FFRct Study

Conditions

Coronary Artery Disease coronary computed tomographic angiography coronary CTA cardiac CT fractional flow reserve plaque

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

The ELUCIDATE FFRct Study

Quick Facts

Study Start:2023-09-01

Study Completion:2024-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06018194

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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.

Contacts and Locations

Study Contact

Todd C Villines, MD

CONTACT

978-468-0508

todd.villines@elucid.com

John Aluru, MBBS

CONTACT

978-468-0508

john.aluru@elucid.com

Principal Investigator

Ziad Ali, MD

PRINCIPAL_INVESTIGATOR

Catholic Health - St. Francis Hospital

Todd C Villines, MD

PRINCIPAL_INVESTIGATOR

Elucid Bioimaging Inc.

Study Locations (Sites)

Cardiovascular Medical Group of Southern California

Beverly Hills, California, 90210

United States

Piedmont Healthcare

Atlanta, Georgia, 30309

United States

Parkview Health

Fort Wayne, Indiana, 46845

United States

Midwest Heart and Vascular Specialists

Overland Park, Kansas, 66211

United States

Valley Health System

Ridgewood, New Jersey, 07450

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Centennial Heart

Nashville, Tennessee, 37203

United States

Ascension Medical Group

Nashville, Tennessee, 37205

United States

University of Virginia

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: 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

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

Study Start Date2023-09-01

Study Completion Date2024-07-31

Study Record Updates

Study Start Date2023-09-01

Study Completion Date2024-07-31

Terms related to this study

Keywords Provided by Researchers

coronary computed tomographic angiography
coronary CTA
cardiac CT
fractional flow reserve
plaque

Additional Relevant MeSH Terms

Coronary Artery Disease