Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05174247

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Erasmusmc

Rotterdam, South Holland, Netherlands, 3015CE

Actively Recruiting

Loading map...

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