Methodology

Steps

Data collection from existing clinical studies with addition of data generated in CARE-IN-HEALTH.

Data integration will pave the way towards the aim to identify and disseminate a resolution of the chronic lipid-driven/-regulated cardiovascular inflammation to in the open access CARE-IN-HEALTH Atlas, as a knowledge-based open access platform.

The knowledge will be used to develop the health care solution CARE-IN-HEALTH MCDSS and point-of-care tool CARE-IN-HEALTH Biosensor.

The tools will be tested in proof-of-concept clinical trials for applications to stay healthy through resolution pharmacology and resolution-health.

STEP 1

Data collection from existing clinical studies with addition of data generated in CARE-IN-HEALTH.

STEP 2

STEP 3

The knowledge will be used to develop the health care solution CARE-IN-HEALTH MCDSS and point-of-care tool CARE-IN-HEALTH Biosensor.

STEP 4

The tools will be tested in proof-of-concept clinical trials for applications to stay healthy through resolution pharmacology and resolution-health.

Clinical studies and proof of concept

To provide the proof-of-concept for the central notion of a lipid driven/regulated chronic inflammation behind the health-to-CVD transition, two clinical trials have been designed. The two studies will address both the health care implementation of the CARE-IN-HEALTH MCDSS and the CARE-IN-HEALTH Biosensor.

Clinical trial POMEGA-2 is a proof-of-concept clinical trial of asymptomatic ASCVD subjects undergoing preventive vascular intervention. A personalized MCDSS-guided classification into high/low risk will be followed by a direct continuation of the POMEGA protocol.

Clinical trial RESOLVIN is a randomized, controlled, open label trial of dietary interventions for citizens.

Open
science approaches

Implementation of open science practices

Adhering to open science principles is both a cornerstone and a prerequisite for CARE-IN-HEALTH success. Indeed, the development of CVD prevention strategies for citizens and in health care through personalized resolution pharmacology and resolution-health will not only require extensive communication and data sharing between consortium partners but most importantly it will necessitate a common agreement of all stakeholders from clinicians and scientists to scientific societies who provide the guidelines and patients. If implementing such a model has the potential to change the paradigm for cardiovascular prevention in Europe, it implies that all stakeholders have timely, relevant, and transparent access to all the necessary data and knowledge for evaluating model performance and impact.