Periodic Reporting for period 1 - COMBINE-CT (Combining CT diagnostic data and interventional approaches for futureproof cardiology care)
Reporting period: 2023-11-01 to 2024-10-31
Current guidelines recommend Coronary Computed Tomography Angiography (CCTA)as a first-line test for the evaluation of coronary artery disease (CAD), positioning it as a ‘gatekeeper’ to the Cath lab. However, the care pathway for CAD patients still involves enormous variability and complexities, which are associated with poorer patient outcomes, including recurrent cardiac events and increased risk of mortality. COMBINE-CT will improve hospital efficiency and patient outcomes by closing the gaps in the existing CAD workflow for chronic patients.
Objective 1: Improve hospital efficiencies through Definitive ischemia diagnosis
The accomplishments in WP1 lay the groundwork for the technical and clinical advancements planned in subsequent work packages. A comprehensive data management plan was drafted and submitted by the end of Month 6, outlining key principles and detailing necessary datasets. Substantial progress was made using local datasets and agreement on the data sharing plan, including signatures was reached in February 2025. Progress has been made in identifying, selecting, and annotating retrospective data. This involves collecting and curating datasets across participating sites such as those in the CODEX-1 study. These efforts ensure the availability of quality data essential for the project's innovative algorithms and clinical studies. Advanced technologies to improve CCTA-based diagnosis were developed. Key achievements include devising automated stenosis algorithms, enhancing image quality, and exploring AI-based methodologies for coronary stenosis analysis. A comprehensive database is being built to train and assess these tools, and patient-specific scan protocols are being standardised across sites.
Objective 2: Improve CAD procedure outcomes and hospital efficiency
A series of semi-structured interviews organised by Philips (PMS) among a diverse group of 167 interventional cardiologists revealed the increasing adoption of coronary CT-angiography (CCTA) in the management of coronary artery disease (CAD) patients.
Interventional cardiologists believe that CCTA-guided percutaneous coronary interventions (PCI) will become part of their clinical routine, despite current challenges in integrating CCTA data into the Cath lab. These challenges include technical issues, workflow disruptions, and intra-hospital politics. Their feedback highlights the need for CCTA data for live guidance to be seamlessly integrated into the well-established workflow of interventional cardiologists.
A prototype (developed by Philips) for a PCI planning & guidance application has been evaluated for usability with interventional cardiologists. A workflow analysis
emphasized the need for an all-in-one solution for anatomy assessment, plaque morphology, and in-lab review. While CCTA is not universally adopted in the invasive diagnostic workup, its use is increasing. Interventional cardiologists, especially younger ones, strongly recommend using CT data in their labs during live PCI. CCTA is particularly valuable in treating chronic total occlusion (CTO) and other complex cases, offering a seamless workflow that increases efficiency and reduces procedure times.
Objective 3: Prove the value of the CCTA-based diagnostic and interventional workflow for patients and hospitals
During the reporting period, significant progress was made in preparing for the three clinical trials associated with the follow-up phase of the CAD patient journey. The protocols for each trial (EVOLVE, ImpaCT and SPCCT-STENT) have been drafted, providing detailed outlines of the study design, objectives, methodologies, and patient inclusion criteria. These drafts create a solid foundation for the subsequent phases and ensure regulatory and scientific standards compliance.
During the monthly clinical site meetings, extensive discussions were conducted to address the logistics of patient recruitment and the processes for obtaining Institutional Review Board (IRB) approval across multiple clinical sites. For EVOLVE, the protocol has already been submitted to the local IRB for CCN and AUMC. Furthermore, eligible patients for the clinical trials have been identified within the retrospective datasets. These efforts aim to streamline the recruitment process and ensure adherence to ethical guidelines, which will help minimise potential delays once the trials begin. Together, these activities represent critical milestones toward launching the clinical trials that will provide the clinical evidence supporting the inclusion of CCTA across the entire workflow for chronic CAD patients.
The accomplishments in WP1 lay the groundwork for the technical and clinical advancements planned in subsequent work packages. A comprehensive data management plan was drafted and submitted by the end of Month 6, outlining key principles and detailing necessary datasets. Substantial progress was made using local datasets and agreement on the data sharing plan, including signatures was reached in February 2025. Progress has been made in identifying, selecting, and annotating retrospective data. This involves collecting and curating datasets across participating sites such as those in the CODEX-1 study. These efforts ensure the availability of quality data essential for the project's innovative algorithms and clinical studies. Advanced technologies to improve CCTA-based diagnosis were developed. Key achievements include devising automated stenosis algorithms, enhancing image quality, and exploring AI-based methodologies for coronary stenosis analysis. A comprehensive database is being built to train and assess these tools, and patient-specific scan protocols are being standardised across sites.
Objective 2: Improve CAD procedure outcomes and hospital efficiency
A series of semi-structured interviews organised by Philips (PMS) among a diverse group of 167 interventional cardiologists revealed the increasing adoption of coronary CT-angiography (CCTA) in the management of coronary artery disease (CAD) patients.
Interventional cardiologists believe that CCTA-guided percutaneous coronary interventions (PCI) will become part of their clinical routine, despite current challenges in integrating CCTA data into the Cath lab. These challenges include technical issues, workflow disruptions, and intra-hospital politics. Their feedback highlights the need for CCTA data for live guidance to be seamlessly integrated into the well-established workflow of interventional cardiologists.
A prototype (developed by Philips) for a PCI planning & guidance application has been evaluated for usability with interventional cardiologists. A workflow analysis
emphasized the need for an all-in-one solution for anatomy assessment, plaque morphology, and in-lab review. While CCTA is not universally adopted in the invasive diagnostic workup, its use is increasing. Interventional cardiologists, especially younger ones, strongly recommend using CT data in their labs during live PCI. CCTA is particularly valuable in treating chronic total occlusion (CTO) and other complex cases, offering a seamless workflow that increases efficiency and reduces procedure times.
Objective 3: Prove the value of the CCTA-based diagnostic and interventional workflow for patients and hospitals
During the reporting period, significant progress was made in preparing for the three clinical trials associated with the follow-up phase of the CAD patient journey. The protocols for each trial (EVOLVE, ImpaCT and SPCCT-STENT) have been drafted, providing detailed outlines of the study design, objectives, methodologies, and patient inclusion criteria. These drafts create a solid foundation for the subsequent phases and ensure regulatory and scientific standards compliance.
During the monthly clinical site meetings, extensive discussions were conducted to address the logistics of patient recruitment and the processes for obtaining Institutional Review Board (IRB) approval across multiple clinical sites. For EVOLVE, the protocol has already been submitted to the local IRB for CCN and AUMC. Furthermore, eligible patients for the clinical trials have been identified within the retrospective datasets. These efforts aim to streamline the recruitment process and ensure adherence to ethical guidelines, which will help minimise potential delays once the trials begin. Together, these activities represent critical milestones toward launching the clinical trials that will provide the clinical evidence supporting the inclusion of CCTA across the entire workflow for chronic CAD patients.
The project is currently in its inception phase.
Most efforts have been directed towards the data sharing agreement, successfully negotiated by the end of 2024. The process, driven by Philips in its coordinator role, included a full overview of the data needs and requirements, and the assignment of different access levels according to the data minimisation principle.
With the data sharing agreement signed, the clinical studies can proceed as planned.
The clinical team has also drafted the protocols for the clinical studies (all multicentre studies) who aligned during monthly meetings with all clinical sites.
Most efforts have been directed towards the data sharing agreement, successfully negotiated by the end of 2024. The process, driven by Philips in its coordinator role, included a full overview of the data needs and requirements, and the assignment of different access levels according to the data minimisation principle.
With the data sharing agreement signed, the clinical studies can proceed as planned.
The clinical team has also drafted the protocols for the clinical studies (all multicentre studies) who aligned during monthly meetings with all clinical sites.