Actively Recruiting
Clinical Trial to Evaluate the Clinical Value and Cost-effectiveness of a Personalized Prevention Program in High Risk Stable Coronary Heart Disease Patients
Led by Tampere University · Updated on 2023-06-12
12000
Participants Needed
26
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized prevention program (PPP) for people with stable coronary heart disease (CHD) who are at high risk of cardiovascular events. The study includes two parts: Part A screens 12,000 stable CHD subjects using biomarkers to identify those at highest risk, while Part B is a randomized clinical trial comparing usual care to the PPP in 2,000 high-risk subjects. The goal is to assess the clinical value and cost-effectiveness of the PPP and validate risk biomarkers for predicting cardiovascular events. Participants in the PPP group will visit the study site six times over three years to receive lifestyle coaching, exercise prescriptions, and medication guidance following European Society of Cardiology guidelines. These activities are supported by digital tools called the CoroPrevention Tool Suite. The usual care group will continue receiving standard care from their physicians and have two study visits during the three years. Participants will undergo evaluations including biomarker measurements, behavioral assessments, questionnaires on nutrition and exercise, and monitoring of cardiovascular events. The study will track outcomes like cardiovascular death, heart attacks, and heart failure over three years. Researchers will also study the impact of behavioral changes, adherence to exercise and medication prescriptions, and the economic value of the prevention program. Safety and progress will be monitored throughout the study period.
CONDITIONS
Brief Title
Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Male or female aged 30 to 80 years on the day of enrollment
- More than 50% blockage in one or more major coronary arteries on angiography or CT within the past year
- Or myocardial infarction (type I or II) during the past year
You will not qualify if you...
- Hospitalization for acute coronary syndrome, myocardial infarction, stroke, coronary revascularization, or acute heart failure within the past 30 days
- New York Heart Association class III-IV heart failure with marked activity limitation
- Uncontrolled arrhythmias such as ventricular tachycardias
- Undergoing dialysis due to severe renal disease
- Diseases severely limiting exercise, such as rheumatoid arthritis or neurological or orthopedic diseases
- Known aplastic or hemolytic anemia
- Non-coronary diseases limiting life expectancy to less than three years, such as malignancy
- Participation in another interventional study
- Inability or unwillingness to attend all scheduled visits or use a smartphone application
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 years
Participants in the PPP arm receive lifestyle coaching and exercise prescriptions over a three year period, supported by digital tools, to help reduce cardiovascular risk.
6 visits over 3 years
Duration - 3 years
Participants in the usual care arm are referred back to their treating physicians and observed without study-driven treatment recommendations.
2 visits over 3 years
Trial Site Locations
Total: 26 locations
1
Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
2
Mehiläinen
Helsinki, Finland
Actively Recruiting
3
Kuopio University Hospital
Kuopio, Finland
Not Yet Recruiting
4
Oulu University Hospital
Oulu, Finland
Actively Recruiting
5
Klinik am See
Berlin, Germany
Not Yet Recruiting
6
CCV-MVZ
Frankfurt, Germany
Withdrawn
7
Heidelberg University
Mannheim, Germany
Not Yet Recruiting
8
Technise Universität Munchen
München, Germany
Not Yet Recruiting
9
Herzklinik Ulm
Ulm, Germany
Not Yet Recruiting
10
Hellenic Red Cross Hospital
Athens, Greece
Not Yet Recruiting
11
Konstantopoulio Hospital
Athens, Greece
Not Yet Recruiting
12
Sismanoglion Hospital
Athens, Greece
Not Yet Recruiting
13
The Biomedical Research Foundation of the Academy Athens
Athens, Greece
Not Yet Recruiting
14
University Hospital Genova
Genova, Italy
Not Yet Recruiting
15
Multi Medica, Care and Research Institute
Milan, Italy
Not Yet Recruiting
16
Casilino Hospital Rome
Rome, Italy
Not Yet Recruiting
17
University Hospital Turin
Turin, Italy
Not Yet Recruiting
18
University of Bialystok
Bialystok, Poland
Not Yet Recruiting
19
Medical University of Silesia
Katowice, Poland
Not Yet Recruiting
20
Jagellonian University Medical College
Krakow, Poland
Not Yet Recruiting
21
University of Lublin
Lublin, Poland
Not Yet Recruiting
22
Nicolaus Copernicus University
Toruniak, Poland
Not Yet Recruiting
23
National Institute of Cardiology
Warsaw, Poland
Not Yet Recruiting
24
Hospital de Santa Cruz-CHLO
Carnaxide, Portugal
Not Yet Recruiting
25
Hospital do Espirito Santo
Lisbon, Portugal
Not Yet Recruiting
26
Hospital Santa Maria-CHULN/FMUL
Lisbon, Portugal
Not Yet Recruiting
Research Team
H
Hanna Marttila, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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