Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT06018194
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06018194
Study Brief:
Protocol Section:
NCT06018194