The European COMBINE-CT project has entered a new phase. Following the development of technologies, the consortium is now commencing clinical validation of an integrated care pathway for patients with coronary artery disease. This combines CT imaging, artificial intelligence and interventional techniques. Five clinical studies are set to demonstrate the added value this approach can offer in diagnosis, treatment planning, interventions and aftercare.
The four-year project was launched in 2023 and is coordinated by Philips. COMBINE-CT has a budget of 10 million euros and is co-funded by the European Union’s Innovative Health Initiative (IHI) and industrial partners. Eleven organisations from six European countries are participating, including Amsterdam UMC. Last year, Philips introduced the Compact Ultrasound 5500CV this week. A new portable ultrasound system that uses artificial intelligence (AI) to speed up cardiac imaging and make it more accessible.
Comprehensive care pathway
Coronary CT angiography (CCTA) is central to the project. The consortium aims to further develop this non-invasive imaging technique from a diagnostic examination into an AI-supported platform for clinical decision-making and treatment planning. To this end, an integrated and largely automated workflow is being developed. This should enable doctors to use the information throughout the entire care pathway to make a diagnosis, select and plan treatment, carry out an intervention and monitor patients after treatment.
According to interventional cardiologist Bimmer Claessen of Amsterdam UMC, research is being conducted into, amongst other things, how AI, CT and interventional X-ray imaging can be used in combination during PCI procedures. The aim is to make relevant information available before, during and after the procedure to better support treatment decisions.
Less invasive examinations
The researchers see particular potential for reducing unnecessary invasive diagnostics. In patients admitted to hospital with possible symptoms of coronary disease, such as chest pain, invasive coronary angiography is used to visualise narrowings and blockages in the coronary arteries. This involves inserting a catheter into the heart via a blood vessel and administering a contrast agent.
According to the project partners, in around 60 per cent of patients undergoing invasive coronary angiography, no significant narrowing or blockage is found. Reliable non-invasive diagnostics could therefore potentially prevent some of these procedures.
According to the consortium, the need for this is growing. Coronary heart disease is a major cause of death worldwide. An ageing population and the increasing prevalence of risk factors such as obesity and type 2 diabetes may lead to a further rise in the number of patients requiring diagnosis and treatment.
Five clinical studies
COMBINE-CT has now launched five studies. The prospective CONVENE study evaluates the complete CCTA-based diagnostic and interventional workflow. CODEX-1 retrospectively examines the accuracy and reproducibility of AI software for CCTA using data from over a thousand patients.
Within the IMPACT study, invasive angiography, measurements of coronary physiology and intracoronary imaging are being used to further improve the diagnostic accuracy of AI-assisted CCTA. Among other things, the study examines the severity of stenoses, the amount and composition of plaque, and coronary physiology.
SPCCT-STENT focuses on patients who have undergone complex or high-risk PCI. They receive non-invasive follow-up using Spectral Photon-Counting CT. This technology utilises detectors capable of distinguishing between different energy levels and is being investigated to improve the visualisation of stents and surrounding tissue.
The EVOLVE study focuses specifically on high-risk patients with type 2 diabetes. Using repeated, AI-enhanced CCTA scans, researchers are searching for new imaging features associated with plaque progression. This information could ultimately contribute to a more personalised prediction of cardiovascular risks.
Clinical added value
The transition to clinical trials should clarify whether the integrated care pathway actually delivers benefits. Among other things, the consortium is investigating whether CCTA can reduce the number of invasive coronary angiographies, increase the efficiency of healthcare providers and lower costs. It is also examining potential improvements in patient experience and treatment outcomes.
In addition to Philips, the public-private consortium comprises Novo Nordisk, various European and Israeli clinical and academic institutions, and the patient organisation EUPATI. The combination of medical imaging, AI, interventional cardiology, health economics and the patient perspective should ultimately clarify whether a CCTA-based care pathway can be more widely implemented within European cardiac centres.
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