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RECRUITING
NCT04433052
NA

Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD

Sponsor: Tampere University

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

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