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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Erasmusmc
RECRUITING
Rotterdam
Contact Information
Primary
Simran Sharma, MD
s.sharma@erasmusmc.nl
+317030420
Backup
Laurens Groenendijk
l.groenendijk@erasmusmc.nl
+31107033612
Time Frame
Start Date: 2021-07-27
Estimated Completion Date: 2025-07-15
Participants
Target number of participants: 528
Treatments
Experimental: The intervention group (FFRct group)
The people in this group receive an FFRct analysis, which will be included in the treatment plan. If the FFRct analysis shows that there are there is no significant narrowing in your case, then in principle no invasive examination (heart catheterization) performed. If the analysis indicates a significant narrowing, then an invasive cardiac catheterization will usually be required are carried out. The final treatment plan will always be reviewed by your doctor tailored to your individual situation
No_intervention: Standard treatment not using result of FFRct analyses
The people in this group receive the regular treatment. This is usually an invasive cardiac catheterization. The additional FFRct analysis is also included in this group, but it is not included in the treatment plan.
Related Therapeutic Areas
Sponsors
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov