About iCARE4CVD

A federated database is a type of database management system that
transparently combines multiple independent databases into a centralized
system that preserves privacy for health data sharing and analysis. This
will keep the data being collected in WP1 secure and allow it to be easily
analysed to help iCARE4CVD achieve its goals.

By conducting a systematic review on the current standard of biomarker
use in CVD, iCARE4CVD will describe how these biomarkers relate to
disease progression, the body’s response to CVD, and their use in current
standard practice.

This will allow us to define correlations between different biomarkers,
identify existing gaps, and enable us to model the entire spectrum of CVD
from early risk to advanced disease progression. 

As individuals who have lived experience along the CVD spectrum,
patients are able to offer a unique and valuable insight that cannot be
gained elsewhere. WP4 will focus on identifying patient reported outcome
measures (PROMs), patient reported experience measures (PREMs), and a
motivational model.

This information will allow us to retrieve information about patient
requirements and preferences regarding health-related decisions,
precision medicine, technology, and data sharing. Altogether we hope to
adapt this to the requirements of healthcare professionals, and facilitate
the integration of iCARE4CVD results into the clinic.

Everything comes together in WP5. By applying cutting-edge AI and
machine learning techniques, this WP will model and analyse the data that
was collected in WP1, assembled in WP2, and facilitated by WP3 and WP4.

These models will aid in defining novel subgroups of CVD patients,
assessing CVD risk prediction, and predicting how patients respond to
treatment to improve outcomes based on individual biomarker profiles.
These models will be evaluated prospectively in WP6 (clinical validation).

The primary objective of WP6 is to validate the models produced in WP5
by analysing the development, risk and progression of CVD, and Heart
Failure.  
 
WP6 will aim to validate the most promising treatment response
prediction model in a Phase 2B trial in the hopes of validating interaction
between biomarker profile and treatment response determined in earlier
WPs.

This means that treatment will be individually adjusted based on the
biomarker profile and compared to a control group (who will receive
standard care). Patients will be randomly allocated to one of these groups
for 15 months, where the main outcome we will look for will be whether
the biomarker guided treatment response leads to an improvement in
CVD condition compared to standard care.  
 
Lastly, WP6 will also focus on continuing the prospective trial in type1
diabetes from WP1 but will enhance the intervention by validating the
model produced in WP5 to predict patients most likely to benefit from
cardio-renal protection therapy. 

In order for the results generated by iCARE4CVD to find their way into
clinical practice, WP7 will focus on developing and implementing cost-
effective, patient-oriented care pathways.

A CVD care pathway is a healthcare management tool that can be used to
coordinate and standardize the care of patients with CVD. They are used
to outline the recommended sequence of treatment and can exist to aid
healthcare professionals such as doctors or even be developed for patient
to use themselves.

By combining the results of WPs 1-6, we aim to discuss these novel care
pathways with patients and healthcare professionals alike, enabling
iCARE4CVD to create tools with real-world applications – such as more
accurate diagnosis, treatment response, and risk prediction. 

iCARE4CVD’s vision to pave the way to better care for individuals with
CVD could not be realised without careful insight into the regulatory, legal,
reimbursement, and policy landscape relevant to CVD. By defining a
roadmap, framework, and a strategy for biomarker and medical AI
developments that is safe, ethical, and successful, WP8 will aim to
facilitate a successful adaption and implementation of iCARE4CVD’s
medical tools.

WP9 will focus on communicating the iCARE4CVD’s progress and results to
everyone that can benefit from our novel research. By facilitating effective
patient-engagement and two-way communication, WP9 provides a
platform for the patient voice within iCARE4CVD.

Through collecting patient feedback and aiding dialogue between patients
and the project, WP9 ensures we follow a patient-centric approach.
Moreover, we will develop a strategic communication and dissemination
plan that delivers tailored messages to all other key target audiences the
project aims to connect with, such as industry, health care professionals,
regulatory authorities, researchers, and citizens. In doing so, WP9 lays the
foundation for future exploitation of project outputs such as the federated
database and novel decision tools.

WP10 focuses on managing the project and coordinating financial and technical reporting,ensuring timely execution of planned work and completion of all WPs.

WP10 duties include monitoring project progress, identifying deviations in the work plan, supporting decision-making, and proposing changes as needed. Ethics management, data management, quality,risk, and financial management, as well as setting up a Technical and Scientific Advisory Boards, are also key components of this WP.