Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Klinik am See
Coordinator of this site? Confirm its status
BerlinGermanyNot yet recruiting
CCV-MVZ
Coordinator of this site? Confirm its status
FrankfurtGermanyWithdrawn
Heidelberg University
Coordinator of this site? Confirm its status
MannheimGermanyNot yet recruiting
Technise Universität Munchen
Coordinator of this site? Confirm its status
MünchenGermanyNot yet recruiting
Herzklinik Ulm
Coordinator of this site? Confirm its status
UlmGermanyNot yet recruiting
Mehiläinen
Coordinator of this site? Confirm its status
HelsinkiFinlandRecruiting
Helsinki University Hospital
Coordinator of this site? Confirm its status
HelsinkiFinlandRecruiting
Kuopio University Hospital
Coordinator of this site? Confirm its status
KuopioFinlandNot yet recruiting
Oulu University Hospital
Coordinator of this site? Confirm its status
OuluFinlandRecruiting
Sismanoglion Hospital
Coordinator of this site? Confirm its status
AthensGreeceNot yet recruiting
The Biomedical Research Foundation of the Academy Athens
Coordinator of this site? Confirm its status
AthensGreeceNot yet recruiting
Konstantopoulio Hospital
Coordinator of this site? Confirm its status
AthensGreeceNot yet recruiting
Hellenic Red Cross Hospital
Coordinator of this site? Confirm its status
AthensGreeceNot yet recruiting
University Hospital Genova
Coordinator of this site? Confirm its status
GenovaItalyNot yet recruiting
Multi Medica, Care and Research Institute
Coordinator of this site? Confirm its status
MilanItalyNot yet recruiting
Casilino Hospital Rome
Coordinator of this site? Confirm its status
RomeItalyNot yet recruiting
University Hospital Turin
Coordinator of this site? Confirm its status
TurinItalyNot yet recruiting
University of Bialystok
Coordinator of this site? Confirm its status
BialystokPolandNot yet recruiting
Medical University of Silesia
Coordinator of this site? Confirm its status
KatowicePolandNot yet recruiting
Jagellonian University Medical College
Coordinator of this site? Confirm its status
KrakowPolandNot yet recruiting
University of Lublin
Coordinator of this site? Confirm its status
LublinPolandNot yet recruiting
Nicolaus Copernicus University
Coordinator of this site? Confirm its status
ToruniakPolandNot yet recruiting
National Institute of Cardiology
Coordinator of this site? Confirm its status
WarsawPolandNot yet recruiting
Hospital de Santa Cruz-CHLO
Coordinator of this site? Confirm its status
CarnaxidePortugalNot yet recruiting
Hospital Santa Maria-CHULN/FMUL
Coordinator of this site? Confirm its status
LisbonPortugalNot yet recruiting
Hospital do Espirito Santo
Coordinator of this site? Confirm its status
LisbonPortugalNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.