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

NCT05174247 | Recruiting

• 1 other identifier: MEC-2021-0189
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain; Epicardial Plaques

Keywords

Stable chest pain; Coronary Angiography; major epicardial vessel stenosis

Outcome Measures

Primary Outcomes (1)

• Rate of unnecessary ICA

  Unnecessary ICA is defined as any ICA without hemodynamically significant CAD. The leading indicator for the evaluation of significant CAD is the functional measurement (FFR/iFR). If functional measurements are not available, then significant CAD is indicated by quantitative coronary angiography or ultimately by visual estimation (eyeballing).

  90 days

Secondary Outcomes (11)

• Rate of unnecessary ICA

  1 year

• Rate of major adverse cardiac events (MACE)

  90 days; 1 year

• Number of additional non-invasive tests for coronary artery disease (CAD) assessment

  90 days; 1 year

• Number of coronary revascularisations (planned/unplanned)

  90 days; 1 year

• Rate of cardiovascular death

  90 days; 1 year

Study Arms (2)

The intervention group (FFRct group)

EXPERIMENTAL

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

Other: FFRct analysis

Standard treatment not using result of FFRct analyses

NO INTERVENTION

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.

Interventions

FFRct analysis OTHER

Software analysis of Cardiac CT to show extent of pericardial stenoses

The intervention group (FFRct group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmusmc

Rotterdam, South Holland, 3015CE, Netherlands

RECRUITING

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricardo PJ Budde, MD PHD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Alexander Hirsch, MD PHD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simran Sharma, MD

CONTACT

+317030420; s.sharma@erasmusmc.nl

Laurens Groenendijk

CONTACT

+31107033612; l.groenendijk@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 30, 2021
• Study Start: July 27, 2021
• Primary Completion: April 15, 2025
• Study Completion: July 15, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)