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RECRUITING
NCT05174247
NA

Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

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.

Official title: Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain to Reduce Unnecessary Invasive Coronary Angiography

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

528

Start Date

2021-07-27

Completion Date

2025-07-15

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

OTHER

FFRct analysis

Software analysis of Cardiac CT to show extent of pericardial stenoses

Locations (1)

Erasmusmc

Rotterdam, South Holland, Netherlands