Actively Recruiting
Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain to Reduce Unnecessary Invasive Coronary Angiography
Led by Erasmus Medical Center · Updated on 2024-09-19
528
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the addition of Fractional Flow Reserve from coronary computed tomography (FFRct) in the diagnostic pathway for patients with stable chest pain, a common symptom of coronary artery disease (CAD). The study focuses on patients whose initial Coronary Computed Tomography Angiography (CCTA) shows significant narrowing of the coronary arteries. Since CCTA alone sometimes leads to unnecessary invasive coronary angiography (ICA), the study investigates whether adding FFRct can better identify hemodynamically significant stenoses and reduce unneeded invasive procedures. Participants are randomly assigned to one of two groups. One group receives the standard care, typically involving invasive coronary angiography after CCTA. The other group receives an FFRct analysis based on their CCTA images, which is a non-invasive software method that helps assess the functional significance of artery narrowing. If FFRct shows no significant narrowing, invasive angiography may be avoided. Treatment plans are reviewed and personalized by physicians. The study compares outcomes between these two diagnostic approaches. During the study, participants undergo initial CCTA and then the assigned diagnostic approach. Researchers will monitor the rate of unnecessary invasive coronary angiographies within 90 days as the primary outcome. Additional measures include rates of major cardiac events, need for further tests or revascularizations, quality of life assessments, and cost-effectiveness at both 90 days and one year. Follow-up and adherence to the diagnostic pathway are carefully tracked to assess the impact of adding FFRct to routine care.
CONDITIONS
Brief 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 with recent CCTA showing 50% to less than 90% narrowing in a major coronary artery with diameter 2 mm or more
You will not qualify if you...
- Unable to provide informed consent
- Unstable angina according to ESC guidelines
- Unstable clinical condition
- Expected inability to complete or comply with follow-up
- History of coronary revascularisation
- Non-invasive or invasive diagnostic testing for CAD within past 12 months (except exercise ECG)
- Unsuitable for revascularisation due to comorbidities or anatomy
- Poor CT image quality preventing FFRct analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 1 week
Participants undergo Coronary Computed Tomography Angiography (CCTA) to detect or exclude significant coronary stenosis.
1 visit (in-person)
Duration - Concurrent with Diagnostic Evaluation
Participants in the intervention group receive FFRct analysis using software on the already acquired CCTA images to assess hemodynamic significance of coronary stenosis.
No additional visits; analysis of existing images
Duration - Up to 90 days
Based on diagnostic results, participants either proceed with invasive coronary angiography (ICA) or are managed without it. The treatment plan is tailored to each participant's individual situation.
1 to 2 visits depending on need for invasive procedures
Duration - Up to 1 year
Participants are monitored for outcomes including unnecessary invasive procedures, cardiac events, quality of life, and other health measures.
Periodic follow-up visits up to 1 year
Trial Site Locations
Total: 1 location
1
Erasmusmc
Rotterdam, South Holland, Netherlands, 3015CE
Actively Recruiting
Research Team
S
Simran Sharma, MD
L
Laurens Groenendijk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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