Personalized prevention program for patients with high-risk stable coronary heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the clinical value and cost-effectiveness of a personalized prevention program (PPP) for patients with high-risk stable coronary heart disease (CHD). It consists of two parts: the first part involves screening 12,000 subjects to validate biomarkers for risk stratification, while the second part includes a randomized clinical trial with 2,000 high-risk subjects assigned to either the PPP or usual care. The study aims to assess the impact of the PPP on reducing cardiovascular events and to explore the economic benefits of this personalized approach.

Why it matters

Who can join: the full rules

Eligible study subjects must meet all of the following inclusion criteria:

1. Informed consent form signed by the study subjects.
2. Male or female aged 30 to 80 years on the day of enrolment.
3. \> 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:

1. 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.
2. Subjects with NYHA class III-IV heart failure i.e. marked limitation in activity due to symptoms, comfortable only at rest.
3. Uncontrolled arrhythmias such as ventricular tachycardias.
4. Subjects undergoing dialysis due to severe renal disease.
5. Diseases that severely disable exercising (per investigator's judgement), such as rheumatoid arthritis, neurological or orthopaedic diseases.
6. Known aplastic or haemolytic anaemia.
7. Concomitant non-coronary disease, such as malignancy that limits life expectancy to less than three years.
8. Concurrent participation in another interventional study.
9. Subjects not able and/or willing to attend all scheduled visits and comply with all study procedures and use a smartphone application.

Where it's running

• Helsinki University Hospital
  Helsinki, Finland Recruiting
• Mehiläinen
  Helsinki, Finland Recruiting
• Oulu University Hospital
  Oulu, Finland Recruiting
• Kuopio University Hospital
  Kuopio, Finland Not yet recruiting
• Klinik am See
  Berlin, Germany Not yet recruiting
• Ccv-Mvz
  Frankfurt, Germany Withdrawn

Study contacts

• Study coordinator: Hanna Marttila, MSc
• Email: hanna.marttila@tuni.fi
• Phone: +358407240771

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.