Chest PainFusionNCT05174247
Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain
A study testing FFRct analysis in people with Chest Pain and Epicardial Plaques, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Epicardial Plaques
- What is being tested?
- FFRct analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Jul 2021to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmusmc
Rotterdam, South Holland, 3015CE
Laurens Groenendijk, 31 10 7033612, imaging.trialbureau@erasmusmc.nl
Ricardo PJ Budde, MD
About this study
Official title: Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain to Reduce Unnecessary Invasive Coronary Angiography
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.
Read the detailed description
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.
- Conditions
- Chest Pain, Epicardial Plaques
- Being tested
- FFRct analysis
- Keywords
- Stable chest pain, Coronary Angiography, major epicardial vessel stenosis
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFRct analysisOther
Software analysis of Cardiac CT to show extent of pericardial stenoses
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90 days
Secondary outcomes (11)
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).
Measured: 1 year
Rate of major adverse cardiac events (MACE)
Including all-cause mortality, non-fatal myocardial infarction (MI), and unplanned hospitalization leading to urgent revascularisation,
Measured: 90 days; 1 year
Number of additional non-invasive tests for coronary artery disease (CAD) assessment
Measured: 90 days; 1 year
Number of coronary revascularisations (planned/unplanned)
Measured: 90 days; 1 year
Rate of cardiovascular death
Measured: 90 days; 1 year
Rate of complications during and after ICA
Measured: 90 days; 1 year
Rate of non-fatal stroke
Measured: 90 days; 1 year
EuroQoL 5-Dimension 5-Level (EQ5D5L) to measure quality of life
The scale used is the EQ5D5L index with a minimum value of 0 and a maximum value of 1. Higher score means that there is a higher impact on health-related quality of life.
Measured: 90 days; 1 year
Seattle Angina Questionnaire (SAQ) to quantify patients' symptoms of angina and the extent to which their angina affects their quality of life
The SAQ is a self-report instrument with 19 items that, when scored according to the author's recommendations, yields five subscale scores: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.
Measured: 90 days; 1 year
36-Item Short Form Survey (SF-36) to measure quality of life
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: 90 days; 1 year
Cost-effectiveness
Calculated using the total costs (in euros) of the initial diagnostic tests, any additional tests or treatments for coronary artery disease, hospital admissions for suspected cardiac events and other costs that can be attributed to possible coronary artery disease.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start27 Jul 2021
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S.P. Sharma, Erasmus Medical Center
- Investigators
- Ricardo PJ Budde, MD PHD, Principal investigator, Erasmus Medical CenterAlexander Hirsch, MD PHD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174247
- Sponsor's protocol ID
- MEC-2021-0189
- Acronym
- Fusion
- Status last verified
- Sep 2024
- First submitted
- 15 Nov 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain to Reduce Unnecessary Invasive Coronary Angiography
- ClinicalTrials.gov ID
- NCT05174247
- Acronym / sponsor ID
- Fusion / MEC-2021-0189
- Conditions
- Chest Pain, Epicardial Plaques
- Keywords
- Stable chest pain, Coronary Angiography, major epicardial vessel stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group (FFRct group) | Experimental | Other: FFRct analysisThe 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFRct analysisSoftware analysis of Cardiac CT to show extent of pericardial stenoses | Other | The intervention group (FFRct group) |
Primary outcome
Rate of unnecessary ICA
Time frame: 90 days
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).
11 secondary outcomes
Rate of unnecessary ICA
Time frame: 1 year
Rate of major adverse cardiac events (MACE)
Time frame: 90 days; 1 year
Number of additional non-invasive tests for coronary artery disease (CAD) assessment
Time frame: 90 days; 1 year
Number of coronary revascularisations (planned/unplanned)
Time frame: 90 days; 1 year
Rate of cardiovascular death
Time frame: 90 days; 1 year
Rate of complications during and after ICA
Time frame: 90 days; 1 year
Rate of non-fatal stroke
Time frame: 90 days; 1 year
EuroQoL 5-Dimension 5-Level (EQ5D5L) to measure quality of life
Time frame: 90 days; 1 year
Seattle Angina Questionnaire (SAQ) to quantify patients' symptoms of angina and the extent to which their angina affects their quality of life
Time frame: 90 days; 1 year
36-Item Short Form Survey (SF-36) to measure quality of life
Time frame: 90 days; 1 year
Cost-effectiveness
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo PJ Budde, MD PHD principal investigator
Erasmus Medical Center
Alexander Hirsch, MD PHD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFRct analysis in people with Chest Pain and Epicardial Plaques, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simran Sharma, MD (+317030420, s.sharma@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of unnecessary ICA (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.