Fractional Flow Reserve Derived From Computed Tomography Coronary Angiography in the Assessment and Management of Stable Chest Pain

NCT03187639 | Completed Phase 4 DMC

• 1 other identifier: The FORECAST Trial
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

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)

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; CT coronary angiography; FFRct; Rapid access chest pain clinic; Stable chest pain; Resource utilisation; Quality of life

Outcome Measures

Primary Outcomes (1)

• Resource utilisation

  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.

  9 months

Secondary Outcomes (2)

• Quality of Life

  9 months

• MACE

  9 months

Study Arms (2)

FFRct default primary investigation

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Interventions

FFRct DIAGNOSTIC_TEST

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.

FFRct default primary investigation

Standard care DIAGNOSTIC_TEST

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.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

Southampton Clinical Trials Unit

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Hlatky MA, Wilding S, Stuart B, Nicholas Z, Shambrook J, Eminton Z, Fox K, Connolly D, O'Kane P, Hobson A, Chauhan A, Uren N, Mccann GP, Berry C, Carter J, Roobottom C, Mamas M, Rajani R, Ford I, Douglas PS, Curzen N. Randomized comparison of chest pain evaluation with FFRCT or standard care: Factors determining US costs. J Cardiovasc Comput Tomogr. 2023 Jan-Feb;17(1):52-59. doi: 10.1016/j.jcct.2022.09.005. Epub 2022 Sep 24.

  PMID: 36216700 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: December 4, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 25, 2021
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)