Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
- Conditions
- Coronary Heart Disease
- Interventions
- Behavioral: personalised prevention program (PPP)
- Registration Number
- NCT04433052
- Lead Sponsor
- Tampere University
- Brief 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
- Detailed Description
Primary Objectives:
PART A:
* To prospectively validate biomarkers in risk stratification among stable CHD subjects, i.e. evaluation of the biomarker performance in accurately predicting CV events including CV death, nonfatal MI, HF events
* To identify high-risk CHD subjects for the subsequent RCT, i.e. 15-20% of the screened patient population at the highest risk
PART B
• To demonstrate whether a personalised prevention (PPP) strategy in high-risk CHD subjects results in a decreased risk of cardiovascular (CV) events (CV death, nonfatal myocardial infarction (MI) or heart failure (HF) events) as compared to the local usual care (UC)
Secondary Objectives:
* To evaluate the difference between the PPP arm to the UC arm as listed in section outcomes.
* To evaluate the health economic value of the PPP
* To prospectively study associations (in all enrolled subjects) between separate biomarkers (CERT2, hs-troponin, proBNP, Cystatin C) or their score (CoroPredict)
In addition to the above-listed primary and secondary objectives of the study, the following analysis will be carried out based on the data to be collected during the trial:
* Effect of personalised prevention on behavioural change.
* Effect of behavioural change on CV outcomes and blood pressure.
* Identification of key components and risk factors affecting effectiveness of the PPP.
* Inter-relationship between nutrition and exercise will be evaluated. Nutrition parameters will be based on questionnaires and biomarkers (Trimethylamine N-oxide (TMAO), Trimethyllysine (TML), carnitines and their metabolites).
* Effect of the use of the CoroPrevention Tool Suite (EXPERT tool) on the agreement between exercise prescriptions generated by cardiovascular nurses to subjects with CVD, and the ESC guideline-directed exercise prescriptions
* Effect of greater adherence to EXPERT tool-driven exercise prescriptions by clinicians and subjects, on CVD risk, physical fitness, and prognosis (hospitalisations, adverse events, mortality) in subjects with CVD.
* Effect of the use of the EXPERT tool-driven medication decision support system on the agreement between medication prescriptions generated by cardiovascular nurses to subjects with CVD, and the ESC guideline-directed medication prescriptions
* Effect of better adherence by both clinicians and subjects to ESC guideline prescriptions, driven by the medication decision support system within the EXPERT tool, on CVD risk and prognosis (hospitalisations, adverse events, mortality) in subjects with CVD.
* Investigation of the user experience and user acceptance of the CoroPrevention Tool Suite.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Personalised prevention program (PPP) personalised prevention program (PPP) Participants will be invited to return to the study site six times over a three year period to receive lifestyle coaching and exercise prescriptions. Eupropean Society of Cardiology/European Association of Preventive Cardiology (ESC/EAPC) -designed lifestyle counselling will be partially delivered by novel smartphone applications. Participants will also receive pharmaceutical treatment according to the ESC guideline for chronic coronary syndromes.
- Primary Outcome Measures
Name Time Method To demonstrate whether a PPP strategy in high-risk CHD subjects results in a decreased risk of CV events (CV death, nonfatal MI or HF events) compared to the UC 3 years follow-up • The time from randomisation to the occurrence of the first CV event included in the composite endpoint of the study (CV death, nonfatal MI, HF events) over 3 years follow-up.
- Secondary Outcome Measures
Name Time Method To evaluate the difference between PPP arm to the UC arm in 3 years follow-up Incidence of additional clinical endpoints: diabetes mellitus type 2 (DM2), chronic kidney disease (CKD), peripheral artery disease (PAD) and hypertension
To evaluate the health economic value of the PPP 3 years follow-up o A cost-effectiveness analysis of PPP versus UC will be undertaken, based on evidence from the randomised clinical trial (RCT) portion of the study, using within-trial analysis and long-term cost-effectiveness modelling for the six countries participating in the CoroPrevention trial: Finland, Poland, Greece, Portugal, Italy, and Germany.
• To prospectively study associations (in all enrolled subjects) between separate risk biomarkers (CERT2, hs-troponin , proBNP, Cystatin C) or their score (CoroPredict) and 3 years follow-up * Primary composite CV event (CV death, MI, HF events)
* Specific CV events (CV death, nonfatal MI, HF events) separately
* Specific secondary CV events (unstable angina, stroke, coronary revascularisations)
* Incidence of DM2, CKD, PAD and hypertension
Trial Locations
- Locations (26)
Helsinki University Hospital
🇫🇮Helsinki, Finland
Kuopio University Hospital
🇫🇮Kuopio, Finland
CCV-MVZ
🇩🇪Frankfurt, Germany
Konstantopoulio Hospital
🇬🇷Athens, Greece
Oulu University Hospital
🇫🇮Oulu, Finland
Sismanoglion Hospital
🇬🇷Athens, Greece
Multi Medica, Care and Research Institute
🇮🇹Milan, Italy
Mehiläinen
🇫🇮Helsinki, Finland
Klinik am See
🇩🇪Berlin, Germany
Technise Universität Munchen
🇩🇪München, Germany
Heidelberg University
🇩🇪Mannheim, Germany
Herzklinik Ulm
🇩🇪Ulm, Germany
Hellenic Red Cross Hospital
🇬🇷Athens, Greece
The Biomedical Research Foundation of the Academy Athens
🇬🇷Athens, Greece
University Hospital Genova
🇮🇹Genova, Italy
Casilino Hospital Rome
🇮🇹Rome, Italy
University of Bialystok
🇵🇱Białystok, Poland
University Hospital Turin
🇮🇹Turin, Italy
Medical University of Silesia
🇵🇱Katowice, Poland
Jagellonian University Medical College
🇵🇱Kraków, 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