To assess the impact of adding FFRct analysis to CCTA on the rate of unnecessary invasive coronary angiography (ICA) in patients with stable chest pain that have a >=50% but less than 90% anatomical stenosis on CCTA in any major epicardial vessel…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the percentage of unnecessary ICA at 90 days.
Unnecessary ICA is defined as an ICA without hemodynamically significant
coronary artery disease (CAD).
ICA with no hemodynamically significant CAD is defined as no invasive FFR <=
0.80 or no iFR <= 0.89 in a coronary artery >= 2 mm;
or if FFR or iFR is not performed, no >= 50% stenosis on the quantitative
coronary angiography (QCA) in a coronary >= 2 mm; or if QCA is also not
available, no visual stenosis of >= 70% or in the case of the main stem no
stenosis of >=50% in a coronary artery >= 2 mm.
Secondary outcome
• Percentage of unnecessary ICA after 1 year
The following endpoints are determined after 90 days and after 1 year:
• Serious Adverse Cardiac Events (MACE), including all-cause mortality,
non-fatal myocardial infarction (MI), and unplanned
hospitalization leading to urgent revascularization
• Cost-effectiveness analysis and budget impact analysis
• Number of additional non-invasive tests for CAD assessment
• All coronary revascularizations (planned / unplanned)
•Quality of life
• Cardiovascular mortality
• Complications after ICA
• Non-fatal stroke
Background summary
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.
Study objective
To assess the impact of adding FFRct analysis to CCTA on the rate of
unnecessary invasive coronary angiography (ICA) in patients with stable chest
pain that have a >=50% but less than 90% anatomical stenosis on CCTA in any
major epicardial vessel with a diameter of >= 2 mm.
Study design
Randomised controlled trial (RCT) and combined post-hoc analysis in control
group.
Study burden and risks
The patient burden to participate is negligible since CCTA data that were
already acquired will be used for additional analysis.
The FFRct functional analysis of CCTA images does not require extra site
visits. To assess QOL, participating patients will have to fill in 3
questionnaires at baseline, at 90 days and at 1 year.
Additionally, patients fill in a questionnaire as an addition to the case
record form to be certain no events during follow-up were missed.
Clinical follow-up will be collected at 90 days and 1 year by a visit to the
outpatient clinic and/or by telephone call.
The risks of false negative FFRct resulting in cardiac events is extremely low
and therefore in our view acceptable. The data available from literature shows
the per patient sensitivity of FFRct to be very high (up to 96%) and false
negative ratio to be very low (4%). In patients with a negative FFRct result
(>0.80) the rate of MACE during follow-up is extremely low.
A patient may benefit from participation, as it is expected that a part of the
intervention group will not need invasive diagnostics.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76830.078.21 |