Using FFRct to improve diagnosis in patients with stable chest pain
Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain to Reduce Unnecessary Invasive Coronary Angiography
This study is testing if a new heart imaging technique can help doctors better diagnose patients with stable chest pain and avoid unnecessary procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 528 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT05174247 on ClinicalTrials.gov |
What this trial studies
This study evaluates the addition of Fractional Flow Reserve from coronary computed tomography (FFRct) analysis to the diagnostic pathway for patients experiencing stable chest pain. Patients who have undergone Coronary Computed Tomography Angiography (CCTA) showing significant stenosis (≥50% luminal narrowing) will be assessed using FFRct to determine the hemodynamic significance of the stenosis. The goal is to reduce unnecessary invasive procedures by accurately identifying which patients require revascularization. This approach aims to enhance diagnostic accuracy and patient outcomes in managing coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stable chest pain and CCTA results showing 50-90% stenosis in major epicardial vessels.
Not a fit: Patients with unstable angina, recent coronary revascularization, or those unsuitable for revascularization will not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to more accurate diagnoses and reduce unnecessary invasive procedures for patients with stable chest pain.
How similar studies have performed: Other studies have shown promise in using FFRct for improving diagnostic accuracy in coronary artery disease, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Stable chest pain and the patient underwent CCTA which demonstrated ≥50% but less than 90% stenosis in any major epicardial vessel with a diameter ≥ 2 mm. Exclusion Criteria: * Inability to provide informed consent * Unstable angina according to ESC guidelines * Unstable clinical status * Expected inability to complete follow-up and comply with follow-up aspects of the protocol * History of coronary revascularisation * Non-invasive or invasive diagnostic testing for CAD within the past 12 months (with the exception of exercise ECG) * Unsuitable for revascularisation if required (for example due to comorbidities or anatomical features) * Poor CT quality with expected inability to perform FFRct analysis
Where this trial is running
Rotterdam, South Holland
- Erasmusmc — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Ricardo PJ Budde, MD PHD — Erasmus Medical Center
- Study coordinator: Simran Sharma, MD
- Email: s.sharma@erasmusmc.nl
- Phone: +317030420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.