Actively Recruiting
Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain
Led by Erasmus Medical Center · Updated on 2024-09-19
528
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rationale: Patients with stable chest pain enter a diagnostic pathway where Coronary Computed Tomography Angiography (CCTA) is often the first line non-invasive test to detect coronary stenosis. An anatomically significant (≥ 50% luminal narrowing) stenosis on CCTA does however not always cause cardiac ischemia (i.e. hemodynamically significant stenosis). CCTA is often followed by invasive coronary angiography (ICA) to assess the hemodynamic significance of the stenosis which is the key determinant to decide on treatment (revascularization by coronary stenting or surgery). CCTA has a very high negative predictive value but the positive predictive value is moderate. Hence, anatomically significant stenoses on CCTA often turn out not to be hemodynamically significant on ICA. Fractional Flow Reserve from coronary computed tomography (FFRct) analysis is a new non-invasive technique that uses the CCTA images as a basis for complex software based calculations and modelling to provide additional functional information based on the anatomical CCTA images. Thus, FFRct is a totally non-invasive method. Adding the FFRct analysis to the anatomical assessment of CCTA is expected to reduce the number of patients being referred to ICA where no signs of hemodynamically significant stenosis are found on ICA.
CONDITIONS
Official Title
Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Stable chest pain
- Underwent CCTA showing 50% to less than 90% narrowing in any major epicardial vessel with diameter 2 mm or more
You will not qualify if you...
- Unable to provide informed consent
- Unstable angina as defined by ESC guidelines
- Unstable clinical condition
- Expected inability to complete or comply with follow-up requirements
- History of coronary revascularisation
- Non-invasive or invasive testing for coronary artery disease within the past 12 months except exercise ECG
- Unsuitable for revascularisation due to comorbidities or anatomy
- Poor CT scan quality preventing FFRct analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Erasmusmc
Rotterdam, South Holland, Netherlands, 3015CE
Actively Recruiting
Research Team
S
Simran Sharma, MD
CONTACT
L
Laurens Groenendijk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here