Fractional Flow Reserve Derived From Computed Tomography Coronary Angiography in the Assessment and Management of Stable Chest Pain (FORECAST)
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|ClinicalTrials.gov Identifier: NCT03187639|
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Diagnostic Test: FFRct Diagnostic Test: Standard care||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1400 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||FORECAST is a randomised controlled trial comparing 1400 patients with new onset pain who are assigned to either routine assessment or FFRct assessment (n=700 per group)|
|Masking:||None (Open Label)|
|Official Title:||Fractional Flow Reserve Derived From Computed Tomography Coronary Angiography in the Assessment and Management of Stable Chest Pain|
|Actual Study Start Date :||December 4, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: FFRct default primary investigation
All patients undergo FFRct as the default test assuming they have no pre-specified contraindications to CT 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.
Diagnostic Test: FFRct
In the test group all patients who are eligible for CTA will undergo CTA as their default test. Those patients with any coronary stenosis of equal 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.
Active Comparator: Standard care
All patients will be assessed and managed exactly as they are usually treated by the randomising centre and the RACP using the local algorithms interpreted from the NICE Chest Pain of Recent Onset Guidance.
Diagnostic Test: Standard care
All patients in the standard care group 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 sites… (anticipated outcomes include ETT, stress echo, stress MR, nuclear perfusion, CTA, CT calcium, invasive CA, reassurance), in accordance with the local application of the NICE guideline for chest pain of recent onset.
- Resource utilisation [ Time Frame: 9 months ]To determine whether, in a population of patients presenting to RACPC, routine FFRct as a default test is superior, in terms of resource utilisation, when compared to routine clinical pathway algorithms recommended by NICE.
- Quality of Life [ Time Frame: 9 months ]Seattle angina questionnaire, EQ-5D, illness perception
- MACE [ Time Frame: 9 months ]Myocardial infarction, all cause death, unplanned coronary revascularisation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187639
|Contact: Jacqui Nuttall||023 8120 3866||J.Nuttall@soton.ac.uk|
|Contact: Zoe Nicholas||023 8120 email@example.com|
|Southampton Clinical Trials Unit||Recruiting|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Contact: Jacqui Nuttall 023 8120 3866 J.Nuttall@soton.ac.uk|
|Principal Investigator: Nick Curzen, BM(Hons) PhD FRCP|
|Principal Investigator: Colin Berry, BSc MBBS PhD FRCP|