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Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
Sponsor: Tampere University
Summary
Prospective clinical study with two parts: PART A: a prospective biomarker-based risk screening study in coronary heart disease (CHD) subjects PART B: a nested randomized clinical trial (RCT) in an enriched subpopulation of high-risk stable CHD subjects PART A: 12 000 subjects with stable CHD PART B: 2000 subjects with high risk of CV events will be randomized to usual care (UC) or personalised prevention program (PPP) i.e. 1000 subjects per arm. Study purpose is to assess the clinical value and cost-effectiveness of a personalised prevention program (PPP) in high-risk, stable coronary heart disease (CHD) subjects and to prospectively validate risk screening biomarkers
Official title: A Prospective Clinical Trial to Evaluate the Clinical Value and Cost-effectiveness of a Personalized Prevention Program in Patients With High Risk Stable Coronary Heart Disease
Key Details
Gender
All
Age Range
30 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
12000
Start Date
2023-02-01
Completion Date
2026-12
Last Updated
2023-06-12
Healthy Volunteers
No
Conditions
Interventions
personalised prevention program (PPP)
Study subjects in the PPP arm will be invited to return to the study site six times over a three-year period (at V2/start of the study, V3/mo2, V4/mo6, V5/mo12, V6/mo18 and V7/mo36) to receive lifestyle coaching and exercise prescriptions led by a delegated member of the site staff and supervised by the investigator. Information on drug treatment will also be given by the investigator. These activities will be assisted by digital tools specifically designed for this study, the CoroPrevention Tool Suite.
Locations (26)
Helsinki University Hospital
Helsinki, Finland
Mehiläinen
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Klinik am See
Berlin, Germany
CCV-MVZ
Frankfurt, Germany
Heidelberg University
Mannheim, Germany
Technise Universität Munchen
München, Germany
Herzklinik Ulm
Ulm, Germany
Hellenic Red Cross Hospital
Athens, Greece
Konstantopoulio Hospital
Athens, Greece
Sismanoglion Hospital
Athens, Greece
The Biomedical Research Foundation of the Academy Athens
Athens, Greece
University Hospital Genova
Genova, Italy
Multi Medica, Care and Research Institute
Milan, Italy
Casilino Hospital Rome
Rome, Italy
University Hospital Turin
Turin, Italy
University of Bialystok
Bialystok, Poland
Medical University of Silesia
Katowice, Poland
Jagellonian University Medical College
Krakow, Poland
University of Lublin
Lublin, Poland
Nicolaus Copernicus University
Toruniak, Poland
National Institute of Cardiology
Warsaw, Poland
Hospital de Santa Cruz-CHLO
Carnaxide, Portugal
Hospital do Espirito Santo
Lisbon, Portugal
Hospital Santa Maria-CHULN/FMUL
Lisbon, Portugal