Status:
RECRUITING
Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
Lead Sponsor:
Tampere University
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
30-80 years
Phase:
NA
Brief Summary
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 e...
Detailed Description
Primary Objectives: PART A: * To prospectively validate biomarkers in risk stratification among stable CHD subjects, i.e. evaluation of the biomarker performance in accurately predicting CV events i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
12000 Patients enrolled
Trial Details
Trial ID
NCT04433052
Start Date
February 1 2023
End Date
December 1 2026
Last Update
June 12 2023
Active Locations (26)
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1
Helsinki University Hospital
Helsinki, Finland
2
Mehiläinen
Helsinki, Finland
3
Kuopio University Hospital
Kuopio, Finland
4
Oulu University Hospital
Oulu, Finland