Assessing Diagnostic Value of Non-invasive FFR-CT (Fractional Flow Reserve - Computed Tomography)… (NCT05325112) | Clinical Trial Compass
TerminatedNot Applicable
Assessing Diagnostic Value of Non-invasive FFR-CT (Fractional Flow Reserve - Computed Tomography) in Coronary Care in the Emergency Department
Stopped: Sponsor decision to terminate the study
United States13 participantsStarted 2022-07-15
Plain-language summary
This is a prospective multi-center study. All clinically stable, symptomatic patients who present to the emergency department (ED) or observation unit with suspected coronary artery disease (CAD) and who have at least one ≥40% lesion and no lesion \>90% confirmed by CCTA (Coronary Computed Tomography Angiogram) are eligible for enrollment once their CCTA has been completed and their FFR-CT (if applicable) has been ordered. All enrolling sites will have CCTA incorporated into their standard evaluation of chest pain in the ED/observation unit. Non-control sites will have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years
✓. Clinically stable, symptomatic patients who present to ED/observation unit with suspected CAD
✓. CCTA shows at least one ≥40% lesion and no lesions \>90% in at least one major epicardial vessel
✓. FFR-CT processed successfully (if applicable)
✓. EKG with no acute ischemic changes
✓. Willing to comply with all aspects of the protocol, including adherence to follow up visit
✓. Agrees to be included in the study
✓. Able to provide written informed consent
Exclusion criteria
✕. CCTA showing no ≥40% lesion in a major epicardial vessel
✕. CCTA showing a lesion \>90% in a major epicardial vessel
✕
What they're measuring
1
Reclassification rate between the coronary management plan based on the review of the CCTA alone compared to the coronary management plan based on the review of the CCTA and the FFR-CT analysis.