CROSS sectional versus invasive imaging in patients with Heart Failure

Plain English summary of protocol

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 August 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

Dr Peter Swoboda
Scientific, Principal investigator

Pinderfield Hospital
Wakefield
WF1 4DG
United Kingdom

ORCID ID	0000-0001-7162-7079
Email	p.swoboda@leeds.ac.uk

Dr Laura Jones
Public

Light Building, Clarendon Way, University of Leeds
Leeds
LS2 3AA
United Kingdom

Email	l.m.jones@leeds.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England
• Scotland
• Wales

Study participating centres

Results and Publications

Study outputs

Additional files

45988_PIS_V1.1_01Aug2024.pdf

Participant information sheet

Editorial Notes

04/09/2025: University Hospitals of Leicester NHS Trust was removed, and Glenfield Hospital NHS Trust was added to the study participating centres.
20/08/2025: The completion date was changed from 01/04/2029 to 01/08/2029. Study participating centres added.
08/10/2024: Internal review.
22/08/2024: Trial's existence confirmed by West of Scotland REC.