Under construction – not a live service
Sign in
Taking peopleNo phase

Tests a personalized prevention program in people with stable heart disease at high risk

Tests a personalized prevention program in adults with stable coronary heart disease and high risk.

Key facts

Who runs it
Tampere University
Where
Bialystok, Katowice, Krakow, Lublin, Toruniak, and Warsaw, PolandSee the 6 sitesAlso in 5 other countries, 20 sites
Trial code
Registry title
Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
Status
Recruiting
People taking part
12,000 people, planned
Started
1 Feb 2023
Expected to end
Dec 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • personalised prevention program (PPP)
Record updated
12 June 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 30 to 80 with stable coronary heart disease, shown by narrowed heart arteries or a heart attack in the past year.

Age
30 to 80 years
Sex
Men and women can join
Disease stage
Stable coronary heart disease: more than 50% narrowing in one or more major heart arteries on angiography or CT within the past year, or a heart attack (type I or II) in the past year.

Main reasons for not taking part

  • Hospital stay for acute coronary syndrome, heart attack, stroke, heart procedure to restore blood flow or acute heart failure in the past 30 days
  • Heart failure of NYHA class III-IV
  • Uncontrolled arrhythmias such as ventricular tachycardias
  • Dialysis because of severe kidney disease
  • Another illness that limits life expectancy to less than three years

The registry criteria, word for word

Show all 13 criteriaShow less

Other criteria

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 30 and 80 years old?

Where in Poland

Also in 5 other countries, 20 sites

  • University of BialystokBialystok, PolandContact: Karol Kaminski, MD, PhDNot yet recruiting
  • Medical University of SilesiaKatowice, PolandContact: Zbigniew Gasior, MD, PhDNot yet recruiting
  • Jagellonian University Medical CollegeKrakow, PolandContact: Piotor Jankowski, MD, PhDNot yet recruiting
  • University of LublinLublin, PolandContact: Andrzej Wysokinski, MD, PhDNot yet recruiting
  • Nicolaus Copernicus UniversityToruniak, PolandContact: Aldona Kubica, MD, PhDNot yet recruiting
  • National Institute of CardiologyWarsaw, PolandContact: Rafal Dabrowski, MD, PhDNot yet recruiting

About the trial

What the trial wants to find out

Prospective clinical study with two parts:

Read full original descriptionShow less

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

The 2 groups in the trial

  • Personalised prevention program (PPP)Treatment being tested

    Participants will be invited to return to the study site six times over a three year period to receive lifestyle coaching and exercise prescriptions. Eupropean Society of Cardiology/European Association of Preventive Cardiology (ESC/EAPC) -designed lifestyle counselling will be partially delivered by novel smartphone applications. Participants will also receive pharmaceutical treatment according to the ESC guideline for chronic coronary syndromes.

  • Usual care (UC)No study treatment, for comparison

    Participants will be referred back to usual care provided by their treating physicians. It is anticipated that physicians will treat these participants according to local usual medical practices. Patients randomized to UC group will not receive any treatment recommendations nor restrictions by the study investigators or nurses. Randomized UC patients are invited to site visits twice over a three year period.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests a personalized prevention program in people with stable heart disease at high riskGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04433052, who can take part
Record updated
12 June 2023