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Prevention study for Coronary Heart Disease
Official title Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
ClinicalTrials.gov ID: NCT04433052
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 80
You may be able to join if
- Eligible study people must meet all of the following
- Informed consent form signed by the study people.
- 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...
You likely can't join if
- Hospitalisation for acute coronary syndrome, myocardial infarction, stroke, coronary revascularisation or acute heart failure within the preceding...
- people 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.
- people 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.
See the full eligibility criteria
- Eligible study people must meet all of the following
- Informed consent form signed by the study people.
- 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...
- Hospitalisation for acute coronary syndrome, myocardial infarction, stroke, coronary revascularisation or acute heart failure within the preceding one month (30 days). These people can be enrolled after a one-month...
- people 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.
- people 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 treatment study.
- people not able and/or willing to attend all scheduled visits and comply with all study procedures and use a smartphone application.
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- Kuopio, Finland
- Oulu, Finland
- Berlin, Germany
- Frankfurt, Germany
- Mannheim, Germany
- München, Germany
- Ulm, Germany
- Athens, Greece
- Genova, Italy
- Milan, Italy
- Rome, Italy
- Turin, Italy
- Bialystok, Poland
- Katowice, Poland
- Krakow, Poland
- Lublin, Poland
- Toruniak, Poland
- Warsaw, Poland
- Carnaxide, Portugal
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland; Kuopio, Finland; Oulu, Finland; Berlin, Germany; Frankfurt, Germany; Mannheim, Germany and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.