Does CT-derived fractional flow reserve help reduce healthcare costs and improve patient care in a real-world setting?
| ISRCTN | ISRCTN57392292 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57392292 |
| IRAS number | 285996 |
| Secondary identifying numbers | IRAS 285996, CPMS 46652 |
- Submission date
- 22/06/2022
- Registration date
- 29/07/2022
- Last edited
- 09/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Coronary artery disease (CAD) remains the major cause of heart-related deaths and overall deaths in the United Kingdom. Angina is a symptom of chest pains that is a warning of the presence of CAD. In order to investigate patients with possible angina, doctors can perform a CT coronary angiogram (CTCA) that looks to identify CAD. Whilst CTCA is excellent at detecting CAD it cannot determine whether this is causing the patient's symptoms. A new technology, CT-derived fractional flow reserve (FFRCT), was introduced by NHS England in 2018 to help identify the patients with significant CAD that is causing angina. This study aims to look at the patients who had FFRCT and compare them to patients who didn’t have this test to determine whether the new technology has been useful. The researchers will assess its impact on the length of the patient journey, the number of tests the patients required and whether there was any difference in heart attack and death rates.
Who can participate?
Patients aged 18 years and over who underwent a CTCA as part of an investigation for CAD between 2017 and 2020 at participating sites
What does the study involve?
A retrospective analysis of data captured from NHS digital’s datasets.
What are the possible benefits and risks of participating?
There are no specific benefits to the participants involved as their care will have already occurred and this is a retrospective observational study. The benefits are establishing the potential benefit of this technology in the NHS.
Where is the study run from?
Liverpool Heart and Chest Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2019 to August 2023
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Dr Tim Fairbairn, Timothy.Fairbairn@lhch.nhs.uk
Contact information
Principal Investigator
Liverpool Heart and Chest Hospital
Thomas Drive
Liverpool
L14 3PE
United Kingdom
| Phone | +44 (0)151 600 1477 |
|---|---|
| timothy.fairbairn@lhch.nhs.uk |
Study information
| Study design | Pragmatic ‘real world’ multi-centre retrospective observational analytic cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 41963_PIS_V1_Dec20.pdf |
| Scientific title | CT-derived fractional flow reserve in stable heart disease and coronary computed tomography angiography helps improve patient care and societal costs |
| Study acronym | FISH and CHIPS |
| Study objectives | To determine whether a coronary computed tomography angiography (CCTA) and CT-derived fractional flow reserve (FFRCT) diagnostic pathway reduces health-related events, time to diagnosis and overall healthcare costs compared to a ‘standard of care’ CCTA diagnostic chest pain pathway. |
| Ethics approval(s) | Approved 24/02/2021, North West - Liverpool Central Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)2071048118, +44 (0)2071048035, +44 (0)2071048016; liverpoolcentral.rec@hra.nhs.uk), ref: 20/NW/0430 |
| Health condition(s) or problem(s) studied | Cardiovascular disease |
| Intervention | Participants will include all individuals who had a CCTA performed at an institute participating in NHS England’s Innovation and Technology Payment (ITP) programme during 2018-2020. All CCTA 12 months prior to and up to 24 months following the start of an FFRCT programme (total study period 36 months) will be assessed. The cohort from this population that received an FFRCT will be separately identified. Patients will be followed up at 90 days, 12 months and a minimum of 24 months post CCTA for the pre-defined primary and secondary endpoints. |
| Intervention type | Other |
| Primary outcome measure | Collected from NHS digital’s datasets for 90 days, 12 months and a minimum of 24 months follow-up post CCTA: 1. MI event rate, hospitalization for acute coronary syndrome, MI deaths and all-cause death 2. Downstream testing: numbers of non-invasive functional tests, and invasive coronary angiograms without revascularisation performed following the index FFRCT 3. Cost analysis: total cost to the NHS of the index test and all downstream investigations and hospital admissions |
| Secondary outcome measures | Collected from NHS digital’s datasets for 90 days, 12 months and a minimum of 24 months follow-up post CCTA: 1. Time to diagnosis - trust referral to treatment (RTT) time 2. Qualitative assessment of the impact of the FFRCT health technology |
| Overall study start date | 01/01/2019 |
| Completion date | 01/08/2023 |
Eligibility
| Participant type(s) | Patient, Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100000 |
| Key inclusion criteria | 1. Age ≥18 years 2. CCTA for the assessment of coronary artery disease (CAD) |
| Key exclusion criteria | 1. Age <18 years 2. Coronary artery calcium scoring alone 3. CCTA in addition to a second CT investigation for a non-coronary indication (CT transcatheter aortic valve implantation [TAVI], CT aorta) 4. Previous CCTA within 6 months 5. Prior coronary artery bypass graft (CABG)/myocardial infarction (MI) 6. Entry into a separate FFRCT research study during the study timeframe |
| Date of first enrolment | 01/03/2022 |
| Date of final enrolment | 22/06/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Liverpool
L14 3PE
United Kingdom
Sponsor information
Hospital/treatment centre
Thomas Drive
Liverpool
L14 3PE
England
United Kingdom
| Phone | +44 (0)151 600 1000 |
|---|---|
| jennifer.crooks@lhch.nhs.uk | |
| Website | http://www.lhch.nhs.uk/About-Us/ |
"ROR" |
https://ror.org/000849h34 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 26/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results will be submitted for peer review with presentation and publication in high-impact peer-reviewed journals |
| IPD sharing plan | Participant-level data will not be shared as per the Data Access Request Service (DARS) agreement |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 01/12/2020 | 30/06/2022 | No | Yes |
| Protocol file | version 2 | 01/06/2022 | 30/06/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
09/08/2023: The following changes were made to the trial record:
1. The participant type 'Population' was added.
2. The intention to publish date was changed from 01/02/2023 to 26/08/2023.
04/08/2022: Internal review.
29/07/2022: Internal review.
30/06/2022: Trial's existence confirmed by the HRA.
