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

  • End date
    Apr 15, 2025
  • participants needed
  • sponsor
    Erasmus Medical Center
Updated on 6 January 2022


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.


In the Netherlands, annually 180.000 new patients present with stable chest pain - the most common symptom of coronary artery disease (CAD) [1]. Stable chest pain has a 1.5% 1-year mortality and 0.7% incidence of myocardial infarction [2]. The "Kennisagenda" of the Dutch Societies of Radiology and Cardiology include CAD diagnosis as a top 10 priority.

Patients with stable chest pain enter a diagnostic pathway to detect or exclude significant coronary stenosis which is defined as > 50% luminal narrowing.

The "Verbetersignalement pijn op de borst" published by the Zorginstituut, advocates that the diagnosis should be based on a single non-invasive first line test.

Based on the National Institute for Health and Excellence (NICE) and European Society of Cardiology (ESC) guidelines, the Coronary Computed Tomography Angiography (CCTA) is a good option as the first line test in low to intermediate risk patients.

CCTA is the most sensitive non-invasive technique available, but only provides anatomical information. CCTA has an excellent negative predictive value (99%), therefore CCTA can accurately rule out CAD. However the positive predictive value is moderate (64%). Hence, anatomically significant stenoses on CCTA often turn out not to be hemodynamically significant on ICA .

Patients with significant anatomical stenosis on CCTA are often referred for invasive coronary angiography (ICA) to confirm the presence of a stenosis and subsequent revascularization of hemodynamically significant stenoses. To determine the latter, invasive fractional flow reserve (FFR) measurements can be performed during ICA. In FFR, the pressure drop across an anatomical stenosis is measured, yielding a numerical value between 0 and 1, with 1 being normal and 0.80 considered a significant stenosis.

As with all invasive procedures, ICA is associated with morbidity, mortality, patient discomfort, time and costs. Due to the moderate specificity of CCTA, many patients referred for ICA turn out to not have hemodynamically significant coronary stenosis (28-41%) in Dutch populations.

To reduce the percentage of patients referred for ICA without significant CAD, the FFRct can be useful. FFRct is a non-invasive method that uses the already acquired CCTA images to calculate coronary FFR values as they would be expected if measured invasively.

Based on data of two randomised trials conducted in the Netherlands, around 20% of patients with chest pain referred for CCTA have at least 50% anatomical coronary stenosis on CCTA . Prior FFRct studies involved populations of different countries, with different risk and work-up There are no prospective data on the real-world use of FFRct in the Dutch population of stable chest pain patients with stenosis on CCTA. The effect of FFRct in reducing unnecessary ICA or other non-invasive tests compared to CCTA alone in the Dutch health care situation is unknown. Evidence in the specific Dutch situation and population is needed to evaluate the impact and cost-effectiveness in the Dutch healthcare system.

The FUSION study is a randomized controlled trial which will investigate the impact of adding the FFRct analysis in the diagnostic pathway of stable chest pain on the rate of unnecessary ICA's.

Condition Chest Pain, Epicardial Plaques
Treatment FFRct analysis
Clinical Study IdentifierNCT05174247
SponsorErasmus Medical Center
Last Modified on6 January 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note