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.
Plain-language title generated from the registry record
Registry title: Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
Key facts
- Where
- Athens, GreeceSee the 4 sites
Could this be for you?
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?
Source: NCT04433052, who can take part
Where in Greece
- Hellenic Red Cross HospitalAthens, GreeceNot yet recruiting
- Konstantopoulio HospitalAthens, GreeceNot yet recruiting
- Sismanoglion HospitalAthens, GreeceNot yet recruiting
- The Biomedical Research Foundation of the Academy AthensAthens, GreeceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tampere University
- Trial code
- NCT04433052
- Record updated
- 12 June 2023
- Original description
Prospective clinical study with two parts:Read full original descriptionShow less
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
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
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.