Actively Recruiting
Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
Led by Tampere University · Updated on 2023-06-12
12000
Participants Needed
26
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 enrolment.
- More than 50% narrowing in one or more major coronary arteries shown by angiography or CT within the past year.
- Or myocardial infarction (type I or II) within 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 (enrollment possible after a one-month stabilization period).
- Heart failure classified as NYHA class III or IV.
- Uncontrolled arrhythmias such as ventricular tachycardias.
- Receiving dialysis for severe kidney disease.
- Diseases severely limiting exercise ability, such as rheumatoid arthritis or neurological or orthopedic conditions.
- Known aplastic or hemolytic anemia.
- Non-coronary diseases limiting life expectancy to less than three years, such as malignancy.
- Participation in another interventional study.
- Unable or unwilling to attend all scheduled visits, comply with study procedures, or use a smartphone application.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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