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

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

This study is testing a personalized prevention program to see if it can help people with high-risk stable coronary heart disease avoid heart problems better than regular care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 12000 (estimated)
• Ages: 30 Years to 80 Years
• Sex: All
• Sponsor: Tampere University (other)
• Locations: 26 sites (Helsinki and 25 other locations)
• Trial ID: NCT04433052 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 30 to 80 with significant coronary artery stenosis or a recent myocardial infarction.

Not a fit: Patients who have experienced acute coronary events or have severe heart failure symptoms within the last month may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly reduce the risk of cardiovascular events in high-risk patients with stable CHD.

How similar studies have performed: Other studies have shown promise in personalized prevention strategies for cardiovascular diseases, indicating potential success for this approach.

Eligibility criteria

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 this trial is running

Helsinki and 25 other locations

• Helsinki University Hospital — Helsinki, Finland (RECRUITING)
• Mehiläinen — Helsinki, Finland (RECRUITING)
• Kuopio University Hospital — Kuopio, Finland (NOT_YET_RECRUITING)
• Oulu University Hospital — Oulu, Finland (RECRUITING)
• Klinik am See — Berlin, Germany (NOT_YET_RECRUITING)
• CCV-MVZ — Frankfurt, Germany (WITHDRAWN)
• Heidelberg University — Mannheim, Germany (NOT_YET_RECRUITING)
• Technise Universität Munchen — München, Germany (NOT_YET_RECRUITING)
• Herzklinik Ulm — Ulm, Germany (NOT_YET_RECRUITING)
• Hellenic Red Cross Hospital — Athens, Greece (NOT_YET_RECRUITING)
• Konstantopoulio Hospital — Athens, Greece (NOT_YET_RECRUITING)
• Sismanoglion Hospital — Athens, Greece (NOT_YET_RECRUITING)
• The Biomedical Research Foundation of the Academy Athens — Athens, Greece (NOT_YET_RECRUITING)
• University Hospital Genova — Genova, Italy (NOT_YET_RECRUITING)
• Multi Medica, Care and Research Institute — Milan, Italy (NOT_YET_RECRUITING)
• Casilino Hospital Rome — Rome, Italy (NOT_YET_RECRUITING)
• University Hospital Turin — Turin, Italy (NOT_YET_RECRUITING)
• University of Bialystok — Bialystok, Poland (NOT_YET_RECRUITING)
• Medical University of Silesia — Katowice, Poland (NOT_YET_RECRUITING)
• Jagellonian University Medical College — Krakow, Poland (NOT_YET_RECRUITING)
• University of Lublin — Lublin, Poland (NOT_YET_RECRUITING)
• Nicolaus Copernicus University — Toruniak, Poland (NOT_YET_RECRUITING)
• National Institute of Cardiology — Warsaw, Poland (NOT_YET_RECRUITING)
• Hospital de Santa Cruz-CHLO — Carnaxide, Portugal (NOT_YET_RECRUITING)
• Hospital do Espirito Santo — Lisbon, Portugal (NOT_YET_RECRUITING)
• Hospital Santa Maria-CHULN/FMUL — Lisbon, Portugal (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Hanna Marttila, MSc

Conditions: Coronary Heart Disease, Prevention, Biomarkers, Lifestyle