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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
Sponsor:
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief 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)

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diagnostic Test: FFRct Diagnostic Test: Standard care Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
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)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 9 months ]
    Seattle angina questionnaire, EQ-5D, illness perception

  2. MACE [ Time Frame: 9 months ]
    Myocardial infarction, all cause death, unplanned coronary revascularisation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged over 18
  • Primary symptom of chest pain
  • No contraindication to CTA
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Atrial fibrillation of new onset or when rate control has been difficult
  • Known bigemini/trigeminy
  • Prior CABG surgery
  • Allergic to contrast
  • Advanced renal impairment
  • Significant valve disease (severe aortic stenosis or regurgitation; severe mitral regurgitation)
  • Life expectancy <12 months
  • Inclusion in another trial without prior agreement with CI

Information from the National Library of Medicine

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


Contacts
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Contact: Jacqui Nuttall 023 8120 3866 J.Nuttall@soton.ac.uk
Contact: Zoe Nicholas 023 8120 8538 zoe.nicholas@uhs.nhs.uk

Locations
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United Kingdom
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         
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust

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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03187639     History of Changes
Other Study ID Numbers: The FORECAST Trial
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Southampton NHS Foundation Trust:
Coronary artery disease
CT coronary angiography
FFRct
Rapid access chest pain clinic
Stable chest pain
Resource utilisation
Quality of life
Additional relevant MeSH terms:
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Chest Pain
Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Neurologic Manifestations
Signs and Symptoms