NCT05174247 Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain
| NCT ID | NCT05174247 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Chest Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 528 participants |
| Start Date | 2021-07-27 |
| Primary Completion | 2025-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 528 participants in total. It began in 2021-07-27 with a primary completion date of 2025-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Ricardo PJ Budde, MD PHD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT05174247 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chest Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05174247 currently recruiting?
Yes, NCT05174247 is actively recruiting participants. Contact the research team at s.sharma@erasmusmc.nl for enrollment information.
Where is the NCT05174247 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT05174247 clinical trial?
NCT05174247 is sponsored by Erasmus Medical Center. The principal investigator is Ricardo PJ Budde, MD PHD at Erasmus Medical Center. The trial plans to enroll 528 participants.