CROSS sectional versus invasive imaging in patients with Heart Failure
| ISRCTN | ISRCTN12403403 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12403403 |
| IRAS number | 332073 |
| Secondary identifying numbers | 2024-NCT25, CPMS 57653 |
- Submission date
- 22/08/2024
- Registration date
- 30/09/2024
- Last edited
- 08/10/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Each year in the UK at least 60,000 patients are diagnosed with heart failure. Coronary artery disease (narrowing of the blood vessels supplying the heart) is the most common cause of heart failure. It is important to identify coronary artery disease because these patients have an increased risk of dying and may respond less well to modern treatments. Invasive coronary angiography (described below) is often done as the first-line test to identify coronary artery disease in a fifth of patients with heart failure in the UK. However, it is known from work with our patient and public involvement groups and patient charities (including the British Society for Heart Failure Patient Group and Cardiomyopathy UK) that most patients would prefer to avoid invasive coronary angiography if possible. This trial aims to establish if it is possible to reduce the need for invasive angiography in patients with newly diagnosed heart failure.
Who can participate?
Patients presenting with a new diagnosis of heart failure and not known to have coronary artery disease
What does the study involve?
They will be randomly assigned (equal chance) to one of three tests:
1. Invasive coronary angiogram (current NHS practice)- A specialised X-ray test where dye is injected directly into the heart arteries via the groin or wrist. It carries a small risk of serious complications such as stroke. The test exposes patients to radiation and is expensive (NHS tariff up to £1563). Furthermore, there are long waiting lists for the test following many cancellations due to the COVID-19 pandemic.
2. CT coronary angiography - this test is quick, non-invasive and cheaper than invasive angiography (NHS tariff up to £310). It has a high accuracy for the detection of coronary artery disease but can be challenging in certain patient groups such as elderly patients or those with irregular heart rhythms. It also exposes patients to a small dose of ionising radiation.
3. Stress cardiovascular MRI - This test is non-invasive and cheaper than invasive angiography (NHS tariff up to £596) and provides additional information on the structure and function of the heart. The accuracy of this test for detection of coronary artery disease is unproven in patients with heart failure. It does not expose patients to ionising radiation.
The recruitment strategy aims to maximize the inclusion of patients who have been underrepresented in heart failure trials, such as elderly individuals, ethnic minorities, and socio-economically disadvantaged patients. Efforts will be made to reduce barriers to participation, and collaboration with the NIHR Ethnic Minority Research Inclusivity Group will help create a YouTube video explaining the trial's rationale and the importance of participation. The video will be presented in plain language and made available in multiple languages.
The trial is designed to minimize inconvenience for patients by eliminating the need for additional hospital visits. Follow-up will be conducted remotely, primarily through the review of electronic health records. Surveys exploring patient experiences will be sent via online platforms, text messages, or post, based on patient preference. The trial will also assess whether the tests provide good value for money for the NHS.
If the trial shows that non-invasive imaging tests are as effective as invasive angiography, it could lead to a significant reduction in the number of angiographies performed annually in the NHS. This could result in improved patient experience and cost savings without compromising the health outcomes of patients with heart failure.
What are the possible benefits and risks of participating?
Although direct benefits to participants cannot be guaranteed, the information gained might help the treatment of future patients. Participants will have more contact with medical staff, and have more opportunities to ask questions and be informed about their health. All tests in this trial are standard NHS care so there are no additional research tests or additional risks to participating in the study. There is however a small burden of patient time to complete the consent form and questionnaires at baseline, 6 months and 12 months. To minimise inconvenience, questionnaires will be offered in a variety of formats including telephone, postal and online.
Where is the study run from?
University of Leeds (UK)
When is the study starting and how long is it expected to run for?
April 2024 to April 2029
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
p.swoboda@leeds.ac.uk
l.m.jones@leeds.ac.uk
Contact information
Scientific, Principal Investigator
Pinderfield Hospital
Wakefield
WF1 4DG
United Kingdom
 ORCID ID |
0000-0001-7162-7079 |
|---|---|
| p.swoboda@leeds.ac.uk |
Public
Light Building, Clarendon Way, University of Leeds
Leeds
LS2 3AA
United Kingdom
| l.m.jones@leeds.ac.uk |
Study information
| Study design | Multicentre open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Diagnostic, Quality of life |
| Participant information sheet | 45988_PIS_V1.1_01Aug2024.pdf |
| Scientific title | CROSS sectional versus invasive imaging in patients with Heart Failure |
| Study acronym | CROSS-HF |
| Study hypothesis | To establish whether, in patients with heart failure, a strategy of non-invasive imaging with computed tomography coronary angiography (CTCA) or stress cardiovascular magnetic resonance (CMR) is non-inferior to invasive coronary angiography (ICA) in terms of major adverse cardiovascular events (MACE), patient reported outcome measures, and cost-effectiveness. |
| Ethics approval(s) |
Approved 14/08/2024, West of Scotland REC (Ground Floor Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 141 314 0212; WoSREC3@ggc.scot.nhs.uk), ref: 24/WS/0108 |
| Condition | Heart failure |
| Intervention | Participants will be randomised (online) 1:1:1 ratio to either invasive coronary angiogram (ICA), non-invasive imaging with computed tomography coronary angiography (CTCA) or stress cardiovascular magnetic resonance (CMR). Each test is expected to take between 1 h 20 minutes and 1 h 45 minutes. Participants will be asked to complete up to 3 questionnaires at baseline, 6 months and 12 months but completion of each questionnaire is expected to take no more than 20 minutes. Follow-up by review of medical records at NHS sites will be up to 4.5 years and longer-term follow-up through remote data linkage for up to 10 years. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Time to first major adverse cardiovascular event (MACE) measured from randomisation for a minimum of 12 months: MACE defined as any of: 1. All cause death 2. Myocardial Infarction (MI) 3. Heart Failure Hospitalisation |
| Secondary outcome measures | Measured using patient records: 1. Total MACE events (MACE is defined as all-cause mortality, MI and heart failure hospitalisations) 2. Total (first and recurrent) HF hospitalisations 3. KCCQ-CSS at 6 and 12 months 4. Total Cardiovascular (CV) deaths 5. Total all-cause mortality |
| Overall study start date | 01/04/2024 |
| Overall study end date | 01/04/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 3000 |
| Participant inclusion criteria | 1. Onset of symptoms ± signs of heart failure in the past 12 months AND 2.1. Non-elective heart failure hospitalisation (where heart failure was the primary reason for hospitalisation in the opinion of the investigator) OR 2.2. Outpatients with LVEF ≤40% OR 2.3. Outpatients with LVEF >40% and NT-proBNP >300ng/L (sinus rhythm) or >600ng/L (AF) |
| Participant exclusion criteria | 1. Previous investigations for coronary artery disease (CAD), where CAD was identified as the cause of heart failure 2. Clear alternative cause of heart failure (e.g. cardiac amyloidosis or hypertrophic cardiomyopathy) 3. Severe valvular heart disease thought to be the main cause of heart failure 4. Comorbid conditions with lifespan of less than a year (in the opinion of the investigator) |
| Recruitment start date | 01/10/2024 |
| Recruitment end date | 01/04/2028 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Beckett Street
Leeds
LS9 7TF
United Kingdom
Pinderfields General Hospital
Aberford Road
Wakefield
WF1 4EE
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Sponsor information
University/education
Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom
| governance-ethics@leeds.ac.uk | |
| Website | https://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/03/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The success of the trial depends upon the collaboration of all participants. For this reason, credit for the main results will be given to all those who have collaborated in the trial, through authorship and contributorship. Uniform requirements for authorship for manuscripts submitted to medical journals will guide authorship decisions. These state that authorship credit should be based only on substantial contribution to: • conception and design, or acquisition of data, or analysis and interpretation of data • drafting the article or revising it critically for important intellectual content • and final approval of the version to be published • and that all these conditions must be met (www.icmje.org). All collaborators will be listed as contributors for the main trial publication, giving details of roles in planning, conducting and reporting the trial. The CROSS-HF team should be acknowledged in all publications, as should the funder NIHR. Other key individuals will be included as authors or contributors as appropriate and at the discretion of the CROSS-HF TMG. Any disputes relating to authorship will be resolved by the TSC. The Chairs and Independent members of the TSC will be acknowledged, but will not qualify for full authorship, in order to maintain their independence. To maintain the scientific integrity of the trial, data will not be released prior to the first publication of the analysis of the primary endpoint, either for trial publication or oral presentation purposes, without the permission of the Trial Oversight Committee. In addition, individual collaborators must not publish data concerning their participants which is directly relevant to the questions posed in the trial until the first publication of the analysis of the primary endpoint. The funder, the NIHR, has adopted an open access policy for all funded research which means that an electronic copy of all peer-reviewed published papers must be accessible via the UKPMC website. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.1 | 01/08/2024 | 06/09/2024 | No | Yes |
Additional files
Editorial Notes
08/10/2024: Internal review.
22/08/2024: Trial's existence confirmed by West of Scotland REC.
