The third period (P3) of CARDIATEAM continued with the effects and sanitary measures of the COVID-19 pandemic impacting on the recruitment rate of the CARDIATEAM study.  However, by the end of P3, WP2 has achieved in collaboration with WP3, WP4 and WP5, the implementation and adaptation of the study protocol and all related documents in all participating countries. To ensure the accuracy/integrity of the collected data and a harmonious conduction of the study throughout the recruiting sites, a global monitoring has been implemented.

The main achievement for the P3 has been to open centers in all countries involved in the study. Eleven sites have been initiated and other sites initiation visits are planned before summer 2022. P3 ended with a total of 250 patients recruited and first year follow-up have been performed for the first recruits.

The required infrastructure to collect imaging data in the CARDIATEAM cohort has been installed. The CARDIATEAM web-based database platform is operational and has been successfully validated. Participating centres are being trained and certified by transferring collected data to the imaging core labs and uploading the measurements to a central repository. All data flows are in place and quality assurance measures have been implemented. Hereto, a certification process has been put in place as well as continuous monitoring of the core-lab performance. As the rate of patient inclusion has increased in P3, the data-flow to and from the web-platform are put to the test, and modifications and further improvements were implemented on the go, based on the feedback of imaging core-labs and imaging centers.

The database which will collect all clinical, imaging and omics data of the recruited patients has been set up and structured. We have developed an eCRF system to collect clinical data from recruited patients. This system contains functionality allowing the manual, expert review of registered data to avoid errors and missing data. Training sessions for clinical research assistants on the tool have been organised at each of the different sites. A data transfer protocol has been implemented between the main data processing partners to securely push validated records into the central database. Pipelines for processing of clinical data into the database have been established and web-based mining tools to query the content of the database to allow live monitoring of collected data have been developed. The unsupervised machine learning methodology required to analyze the future deep phenotypic data has been set-up and tested.

Like in previous periods, sample collection kits have been distributed to the already recruiting centers As biological sample collection suffers from the delay in patient’s recruitment (see above), the analyses on the omics measurement have not started yet however a first batch of samples has been sent for a successful quality check to LIH .

Concerning animal models, WP7 partners have now finalised the overview of existing preclinical models of metabolic disorders pertinent to the project and submitted a first joint publication. Two models of interest have been selected for the use within the consortium and a join protocol is being finalized to start mid-RP4.