Periodic Reporting for period 4 - CoroPrevention (Personalized Prevention for Coronary Heart Disease)
Reporting period: 2023-03-01 to 2024-02-29
European Coronary Heart Disease (CHD) burden is unsustainable. Better risk stratification tools and personalized care of patients are needed for reducing morbidity and mortality of CHD and the associated economic burden. To this end we have planned to shape and implement a personalized secondary prevention program for patients with
established CHD. This precision strategy will be tested in a prospective trial, the CoroPrevention Trial, a central element of our proposal. We aim to significantly reduce the numbers of coronary events by using outcome risk- and patient characteristics- guided prevention in CHD patients.
1. Prospectively evaluate clinical utility of personalized prevention in CHD
2. Evaluate health economic and social benefits of the personalized prevention in CHD
3. Discover predictive markers of drug treatment response in CHD
4. Improve current ESC guidelines based on RCT validated clinical data
5. Disseminate the refined prevention program to the attention of practitioners, patients, health care payers and policy makers
This program will establish a new economically sustainable personalized treatment practice applicable throughout Europe particularly to those regions where CHD prevention needs upgrading. The used protocols and technologies will carefully assessed by NICE using their standard evaluation methods that will allow independent expert opinions for different European authorities and decision makers. These opinion statements will further be supported by full Health Economics analyses of CoroPrevention Trial.
established CHD. This precision strategy will be tested in a prospective trial, the CoroPrevention Trial, a central element of our proposal. We aim to significantly reduce the numbers of coronary events by using outcome risk- and patient characteristics- guided prevention in CHD patients.
1. Prospectively evaluate clinical utility of personalized prevention in CHD
2. Evaluate health economic and social benefits of the personalized prevention in CHD
3. Discover predictive markers of drug treatment response in CHD
4. Improve current ESC guidelines based on RCT validated clinical data
5. Disseminate the refined prevention program to the attention of practitioners, patients, health care payers and policy makers
This program will establish a new economically sustainable personalized treatment practice applicable throughout Europe particularly to those regions where CHD prevention needs upgrading. The used protocols and technologies will carefully assessed by NICE using their standard evaluation methods that will allow independent expert opinions for different European authorities and decision makers. These opinion statements will further be supported by full Health Economics analyses of CoroPrevention Trial.
During the fourth reporting period, updates for Medication adherence module according to ESC guidelines and implementation of Physical Exercise module and other supportive modules (Nutrition and education, which do not fall under MDR classification of an investigational device) were done by beneficiaries in WP2.
Medication adherence module was accepted by the Finnish Competent Authority FIMEA in 2022 and therefore currently is in use for the clinical trial at study sites in Finland. During this reporting period Physical Exercise and nutrition module was also deployed and used by nurses and patients in the clinical trial. Significant amount of work and time was spent on implementation of Physical Exercise and nutrition modules in Finnish and Portuguese language and to achieve all the essential requirements laid down by MDR.
Beneficiaries in Work Package 2 (TAU, UHAS, UOULU and Uniweb) have revised the design of the other modules of Toolsuite, which are planned to be released during next reporting period. Next release will include smoking cessation, and stress management modules. These modules do not fall under MDR.
Coordinated by beneficiaries in Work Package 1, all the study subject facing user manuals (for e.g. FAQ, Information for use) and other relevant documents were updated to include medical device specific information and the information related to release 2 and 3.1. CRO partners Optimapharm and Vectorb2b together with trial sponsor TAU are co-operating together towards the ethical committee (EC) and competent authority (CA) submissions in the participating countries. Submission and site management activities in Finland, Greece, Poland, and Germany will be managed by Optimapharm CRO whereas Vector B2B will be responsible for management of submission and site management activities in Italy and Portugal. Both Optimapharm and VectorB2B have identified the local submission experts and/or CRAs (Clinical Research Associates) in their respective countries. During this reporting period CA and EC approval were received for Portugal and Poland. All 3 sites in Portugal were also activated to start the enrolment process. Sites activation for Poland is ongoing and sites will be ready to start the trial with Toolsuite package including R1,R2 and R3.1 in Q1 2024.
In Italy, change of the HUB site was announced in Q4 2023. This change was officially accepted by all consortium members in the Steering committee meeting in January 2024. Since then, TAU is working collectively with new Italian site to finalize contracts and financial agreements. Once the amendment process will be completed, VectorB2B will start lodging submission packages to EC and CA.
Currently, in Germany and Greece national HUB centers (consortium beneficiaries) are continuing “Site Agreement” preparations locally with the clinical sites. TAU has provided agreement templates to facilitate the process with information regarding payment principles and data/privacy protection related issues. In Work Package 3, the first clinical sites were activated for patient enrolment in reporting period 3 and during this reporting period 3 other sites in Finland has started the enrolment.
The delays and their consequences have been analysed, and corrective measures have been identified. Also the critical risks were evaluated and updated. Furthermore, intensive data security risk management and data security audit was conducted during this reporting period. After risk mitigation activities, no residual risk was identified and also no major findings were identified during the security audits. During this reporting period monthly security review meeting was held with data mangers between Uniweb and TAU to monitor the security issues. No major threats were identified so far.
European Society of Cardiology (ESC) oversees communication and dissemination activities in CoroPrevention. They have continued to coordinate the outreach efforts such as events/webinars, social media marketing, website improvement, internal news, publications, and external meetings also during the this reporting period. Project’s communication & dissemination strategy plan has been updated in early 2023. The newsletter has been sent in December 2023, and the project has been exposed to more than 30.800 specialists and individuals through interactions at international events. A comprehensive overview of the communication & dissemination activities is provided under the WP8 description.
Project management work has progressed according to the plan despite delays in the project activities.
Medication adherence module was accepted by the Finnish Competent Authority FIMEA in 2022 and therefore currently is in use for the clinical trial at study sites in Finland. During this reporting period Physical Exercise and nutrition module was also deployed and used by nurses and patients in the clinical trial. Significant amount of work and time was spent on implementation of Physical Exercise and nutrition modules in Finnish and Portuguese language and to achieve all the essential requirements laid down by MDR.
Beneficiaries in Work Package 2 (TAU, UHAS, UOULU and Uniweb) have revised the design of the other modules of Toolsuite, which are planned to be released during next reporting period. Next release will include smoking cessation, and stress management modules. These modules do not fall under MDR.
Coordinated by beneficiaries in Work Package 1, all the study subject facing user manuals (for e.g. FAQ, Information for use) and other relevant documents were updated to include medical device specific information and the information related to release 2 and 3.1. CRO partners Optimapharm and Vectorb2b together with trial sponsor TAU are co-operating together towards the ethical committee (EC) and competent authority (CA) submissions in the participating countries. Submission and site management activities in Finland, Greece, Poland, and Germany will be managed by Optimapharm CRO whereas Vector B2B will be responsible for management of submission and site management activities in Italy and Portugal. Both Optimapharm and VectorB2B have identified the local submission experts and/or CRAs (Clinical Research Associates) in their respective countries. During this reporting period CA and EC approval were received for Portugal and Poland. All 3 sites in Portugal were also activated to start the enrolment process. Sites activation for Poland is ongoing and sites will be ready to start the trial with Toolsuite package including R1,R2 and R3.1 in Q1 2024.
In Italy, change of the HUB site was announced in Q4 2023. This change was officially accepted by all consortium members in the Steering committee meeting in January 2024. Since then, TAU is working collectively with new Italian site to finalize contracts and financial agreements. Once the amendment process will be completed, VectorB2B will start lodging submission packages to EC and CA.
Currently, in Germany and Greece national HUB centers (consortium beneficiaries) are continuing “Site Agreement” preparations locally with the clinical sites. TAU has provided agreement templates to facilitate the process with information regarding payment principles and data/privacy protection related issues. In Work Package 3, the first clinical sites were activated for patient enrolment in reporting period 3 and during this reporting period 3 other sites in Finland has started the enrolment.
The delays and their consequences have been analysed, and corrective measures have been identified. Also the critical risks were evaluated and updated. Furthermore, intensive data security risk management and data security audit was conducted during this reporting period. After risk mitigation activities, no residual risk was identified and also no major findings were identified during the security audits. During this reporting period monthly security review meeting was held with data mangers between Uniweb and TAU to monitor the security issues. No major threats were identified so far.
European Society of Cardiology (ESC) oversees communication and dissemination activities in CoroPrevention. They have continued to coordinate the outreach efforts such as events/webinars, social media marketing, website improvement, internal news, publications, and external meetings also during the this reporting period. Project’s communication & dissemination strategy plan has been updated in early 2023. The newsletter has been sent in December 2023, and the project has been exposed to more than 30.800 specialists and individuals through interactions at international events. A comprehensive overview of the communication & dissemination activities is provided under the WP8 description.
Project management work has progressed according to the plan despite delays in the project activities.
In 2060, some 155 million Europeans are projected to be of age 65 or over. Those aged 65 and over will become a much larger share (rising from 18% now to 28% in 2060 of the population). These demographic changes are expected to have substantial consequences for public finances in the EU and thus public spending on long-term care is projected to double, increasing from 1.8% of GDP in 2010 to 3.4% of GDP in 2060 in the EU as a whole22. Given the high prevalence of CHD and continuously aging population in Europe, the prevention of morbidity and mortality in patients with established CHD is a major public health objective and the focus of this project. We aim to significantly reduce the numbers of destructive and expensive events, namely, cardiovascular deaths, myocardial infarctions (MI) and heart failure hospitalizations by using outcome risk- and patient characteristics- guided prevention in CHD patients. Since majority of CHD patients remain stable throughout their life, it is likely to be useful to focus limited health care resources particularly to those who are the most vulnerable. Catching these individuals and preventing their next potential event will be key to reduce individual harm and societal expenses.