Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03187639 |
| Other study ID # |
The FORECAST Trial |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
December 4, 2017 |
| Est. completion date |
December 1, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
University Hospital Southampton NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To determine whether, in a population of patients presenting to the rapid access chest pain
clinic (RACPC), routine FFRct (Fractional Flow Reserve Computed Tomography) as a default test
is superior in terms of resource utilisation when compared to routine clinical pathway
algorithms recommended by the National Institute for Health and Care Excellence (NICE)
Description:
FORECAST is a randomised controlled trial comparing 1400 patients with new onset pain who are
assigned to either routine assessment or FFRct assessment.
This trial aims to test the hypothesis that FFRct, used as the default screening tool for
patients presenting with new onset stable chest pain, would be associated with (i) shorter
time period between initial consultation and definitive management plan; (ii) better patient
experience; (iii) lower overall use of resources.
The UK is well suited to test this hypothesis because of its well established system of Rapid
Access Chest Pain Clinics (RACPC). The majority of patients presenting with stable chest pain
(CP) that is of suspected cardiac origin are referred to such clinics, with a mandated access
time within 2 weeks. The majority of such clinics work to the algorithm recommended in the
NICE guidelines for Chest Pain of Recent Onset (March 2010). Within this guideline, patients
are stratified according to their risk profile and pre-test likelihood of coronary artery
disease (CAD) to outcomes that include discharge, stress test, CTCA (computed tomography
coronary angiography), CT (computed tomography) coronary calcium score and invasive coronary
angiogram.
Given the relative streamlining of this initial assessment of such patients throughout the
country, it facilitates a comparison of strategies in FORECAST.
Once eligibility for the trial is confirmed and informed consent received, patients will be
enrolled in the study and randomised to a treatment group (1:1 ratio)
The 2 strategies for the FORECAST trial are:
[A] TEST: all patients undergo FFRct as the default test, assuming they have no prespecified
contraindications to CT coronary angiography. The result of the FFRct will be conveyed to the
supervising physician within 24 hours and will be used to determine the subsequent management
plan.
[B] REFERENCE: all patients will be assessed and managed exactly as they are usually treated
by that centre and that RACP using the local algorithms interpreted from the NICE Chest Pain
of Recent Onset Guidance.
All patients in the "routine" assessment group (group B) will be assessed according to their
current conventional pathways that are based upon NICE guidelines for Chest Pain of Recent
Onset. The trial will encourage the routine and standard assessment and management of all
patients at these site, (anticipated outcomes include exercise tolerance testing (ETT),
stress echo, stress magnetic resonance imaging (MR), nuclear perfusion, CTA, CT calcium
score, invasive coronary angiography, reassurance), in accordance to the local application of
the NICE guideline for chest pain of recent onset.
In the FFRct group, all patients who are eligible for CTA will undergo CTA as their default
test. Those patients with any coronary stenosis of equal to or >40% data in at least one
major epicardial vessel of stentable/graftable diameter will be referred for FFRct. (NB
Lesions in distal vessels or vessels of a diameter not suitable for stenting/grafting will
not qualify for FFRct if there are no other more significant lesions). In patients in whom
FFRct analysis is performed, FFR will be derived for all vessels. The data derived from this
test will determine their management strategy. The patients in this arm will not follow the
NICE guideline algorithm. Those patients randomised to FFRct with contraindications for CTA
will be asked to take part in a trial registry.
Data will be collected according to detailed specialised methodology for tracking of (i)
resource utilisation including all cardiac-related medications, tests, hospital visits; (ii)
QOL; (iii) clinical events as described above.
Data collection will occur at 3 and 9 month timepoints
