NCT04433052Recruiting
Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
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
Source: ClinicalTrials.gov · Last updated 12 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 12000 (estimated)
- First submitted
- 4 Jun 2020
- Start date
- 1 Feb 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Tampere University
- Diseases
- Coronary artery disease
- NCT number
- NCT04433052
What you commit to
- Study type: Interventional
- Planned participants: 12000
- From 1 Feb 2023 to the primary completion date, 31 Dec 2026
- 26 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Eligible study subjects must meet all of the following inclusion criteria:
- Informed consent form signed by the study subjects.
- Male or female aged 30 to 80 years on the day of enrolment.
- \> 50% stenosis in one or more major coronary arteries on angiography or computerised tomography (CT) performed within the preceding one year (from enrolment visit).
- or Myocardial infarction (type I, II) during the preceding year.
- Eligible study subjects must not meet any of the following exclusion criteria:
- Hospitalisation for acute coronary syndrome, myocardial infarction, stroke, coronary revascularisation or acute heart failure within the preceding one month (30 days). These subjects can be enrolled after a one-month stabilisation period, which begins from the time of the event.
- Subjects with NYHA class III-IV heart failure i.e. marked limitation in activity due to symptoms, comfortable only at rest.
- Uncontrolled arrhythmias such as ventricular tachycardias.
- Subjects undergoing dialysis due to severe renal disease.
- Diseases that severely disable exercising (per investigator's judgement), such as rheumatoid arthritis, neurological or orthopaedic diseases.
- Known aplastic or haemolytic anaemia.
- Concomitant non-coronary disease, such as malignancy that limits life expectancy to less than three years.
- Concurrent participation in another interventional study.
- Subjects not able and/or willing to attend all scheduled visits and comply with all study procedures and use a smartphone application.
Age in the registry: 30 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinik am See Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| CCV-MVZ Coordinator of this site? Confirm its status | Frankfurt | Germany | Withdrawn |
| Heidelberg University Coordinator of this site? Confirm its status | Mannheim | Germany | Not yet recruiting |
| Technise Universität Munchen Coordinator of this site? Confirm its status | München | Germany | Not yet recruiting |
| Herzklinik Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Not yet recruiting |
| Mehiläinen Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Not yet recruiting |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Recruiting |
| Sismanoglion Hospital Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| The Biomedical Research Foundation of the Academy Athens Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| Konstantopoulio Hospital Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| Hellenic Red Cross Hospital Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| University Hospital Genova Coordinator of this site? Confirm its status | Genova | Italy | Not yet recruiting |
| Multi Medica, Care and Research Institute Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Casilino Hospital Rome Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| University Hospital Turin Coordinator of this site? Confirm its status | Turin | Italy | Not yet recruiting |
| University of Bialystok Coordinator of this site? Confirm its status | Bialystok | Poland | Not yet recruiting |
| Medical University of Silesia Coordinator of this site? Confirm its status | Katowice | Poland | Not yet recruiting |
| Jagellonian University Medical College Coordinator of this site? Confirm its status | Krakow | Poland | Not yet recruiting |
| University of Lublin Coordinator of this site? Confirm its status | Lublin | Poland | Not yet recruiting |
| Nicolaus Copernicus University Coordinator of this site? Confirm its status | Toruniak | Poland | Not yet recruiting |
| National Institute of Cardiology Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Hospital de Santa Cruz-CHLO Coordinator of this site? Confirm its status | Carnaxide | Portugal | Not yet recruiting |
| Hospital Santa Maria-CHULN/FMUL Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
| Hospital do Espirito Santo Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.