Skip to main navigationSkip to main content
The University of Southampton
Southampton Clinical Trials Unit

FORECAST

Title

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

Description

This trial aims to test the hypothesis that FFRCT, used as the default screening tool for patients presenting with recent onset stable chest pain, would be associated with (i) shorter rapid time period between initial consultation and definitive management plan; (ii) better patient experience; (iii) lower overall use of resources.

Objectives

Primary Objective:
To determine whether, in a population of patients presenting to RACPC, routine FFRCT as a default test is superior, in terms of resource utilisation at 9 months, when compared to routine clinical pathway algorithms recommended by NICE CG95.

Secondary Objectives:
1.    To compare clinical outcomes between the two groups at 9 months.

2.    To compare the effect on general wellbeing between the two groups at 9 months.

Trial Design

FORECAST is a randomised controlled trial with a sample size of 1400.

Trial Status

Open to Recruitment.

Population

Adults (aged over 18) with primary symptom of chest pain who are deemed to require a test at initial RACPC assessment and are willing and able to provide written informed consent.
 

Trial Team:

Senior Trial Manager:

Jacqui Nuttall (023 8120 3866)

Trial Manager:

Darran Ball (023 8120 5556)

Clinical Data Coordinator:

Lucy Hogan (023 8120 5605)

Contact information

Email: forecast@soton.ac.uk

Fax: 0844 7740 621

SAE Reporting: ctu@soton.ac.uk or 0844 7740 621

 

Essential Trial Documents

FORECAST Protocol v3 20-Mar-2019

FORECAST Informed Consent Form v3 6-Jun-2018

FORECAST Patient Information Sheet v3 6-Jun-2018

FORECAST GP Letter v1 17-Aug-2017

FORECAST Patient Flagging Form v1.0 19.12.2017

FORECAST Patient Invitation Letter v1 17-Aug-2017

FORECAST Poster v1 01-AUG-17

Patient Questionnaires

Effective UK (English) EQ-5D-5L Paper Self complete v1.0

Effective UK (English) EQ-5D-5L Paper Telephone v1.2

FORECAST Patient Satisfaction Questionnaire v2 19-Sep-18

SAQ-7

ISF Documents

FORECAST Site Delegation Log v2 25-Jul-2018

FORECAST Template Patient Screening Log v1 13-Nov-2017

FORECAST Master Patient List v2 25-Jul-2018

FORECAST Serious Adverse Event Report Form v1 21-Feb-2018

FORECAST FFRCT Site Training Record v2 25-Jul-2018

FORECAST Site Visit Log v3 16-Nov-2018

FORECAST Site Set-Up Meeting Slides v5 04-Jun-2018

FORECAST Site Initiation Slides 09-Apr-2018

Database-related Documents

FORECAST eCRF Completion Guidance v2 26-Jul-18

FORECAST Baseline Crib Sheet v1 13-Apr-2018

FORECAST Randomised CT - Radiology Crib Sheet v1 24-May-2018

FORECAST Randomised CT - Cardiology Crib Sheet v1 24-May-2018

FORECAST Final Treatment Plan Crib Sheet v1 13-Apr-2018

FORECAST 3 Month Follow up Crib Sheet v2 26-Jul-2018

FORECAST 9 Month Follow up Crib Sheet v2 26-Jul-2018

User Manuals

FFRCT Instructions for use

Newsletters

FORECAST Newsletter Issue 1 - September 2018

FORECAST Newsletter Issue 2 - January 2019

FORECAST Newsletter Issue 3 - March 2019

FORECAST Newsletter Issue 4 - May 2019

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×