Clinical trial NCT04433052: Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Prevention
Coronary Heart Disease
Biomarkers
Lifestyle
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 12000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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

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 including CV death, nonfatal MI, HF events
* To identify high-risk CHD subjects for the subsequent RCT, i.e. 15-20% of the screened patient population at the highest risk

PART B

• To demonstrate whether a personalised prevention (PPP) strategy in high-risk CHD subjects results in a decreased risk of cardiovascular (CV) events (CV death, nonfatal myocardial infarction (MI) or heart failure (HF) events) as compared to the local usual care (UC)

Secondary Objectives:

* To evaluate the difference between the PPP arm to the UC arm as listed in section outcomes.
* To evaluate the health economic value of the PPP
* To prospectively study associations (in all enrolled subjects) between separate biomarkers (CERT2, hs-troponin, proBNP, Cystatin C) or their score (CoroPredict)

In addition to the above-listed primary and secondary objectives of the study, the following analysis will be carried out based on the data to be collected during the trial:

* Effect of personalised prevention on behavioural change.
* Effect of behavioural change on CV outcomes and blood pressure.
* Identification of key components and risk factors affecting effectiveness of the PPP.
* Inter-relationship between nutrition and exercise will be evaluated. Nutrition parameters will be based on questionnaires and biomarkers (Trimethylamine N-oxide (TMAO), Trimethyllysine (TML), carnitines and their metabolites).
* Effect of the use of the CoroPrevention Tool Suite (EXPERT tool) on the agreement between exercise prescriptions generated by cardiovascular nurses to subjects with CVD, and the ESC guideline-directed exercise prescriptions
* Effect of greater adherence to EXPERT tool-driven exercise prescriptions by clinicians and subjects, on CVD risk, physical fitness, and prognosis (hospitalisations, adverse events, mortality) in subjects with CVD.
* Effect of the use of the EXPERT tool-driven medication decision support system on the agreement between medication prescriptions generated by cardiovascular nurses to subjects with CVD, and the ESC guideline-directed medication prescriptions
* Effect of better adherence by both clinicians and subjects to ESC guideline prescriptions, driven by the medication decision support system within the EXPERT tool, on CVD risk and prognosis (hospitalisations, adverse events, mortality) in subjects with CVD.
* Investigation of the user experience and user acceptance of the CoroPrevention Tool Suite.

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.

Primary outcomes:
measure: To demonstrate whether a PPP strategy in high-risk CHD subjects results in a decreased risk of CV events (CV death, nonfatal MI or HF events) compared to the UC
timeFrame: 3 years follow-up
Secondary outcomes:
measure: To evaluate the difference between PPP arm to the UC arm in
timeFrame: 3 years follow-up
measure: To evaluate the difference between PPP arm to the UC arm in
timeFrame: 3 years follow-up
measure: To evaluate the difference between PPP arm to the UC arm in
timeFrame: 3 years follow-up
measure: To evaluate the difference between PPP arm to the UC arm in
timeFrame: 3 years follow-up
measure: To evaluate the difference between PPP arm to the UC arm in
timeFrame: 3 years follow-up
measure: To evaluate the health economic value of the PPP
timeFrame: 3 years follow-up
measure: • To prospectively study associations (in all enrolled subjects) between separate risk biomarkers (CERT2, hs-troponin , proBNP, Cystatin C) or their score (CoroPredict) and
timeFrame: 3 years follow-up
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Helsinki
country: Finland
facility: Mehiläinen
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Berlin
country: Germany
facility: Klinik am See
city: Frankfurt
country: Germany
facility: CCV-MVZ
city: Mannheim
country: Germany
facility: Heidelberg University
city: München
country: Germany
facility: Technise Universität Munchen
city: Ulm
country: Germany
facility: Herzklinik Ulm
city: Athens
country: Greece
facility: Hellenic Red Cross Hospital
city: Athens
country: Greece
facility: Konstantopoulio Hospital
city: Athens
country: Greece
facility: Sismanoglion Hospital
city: Athens
country: Greece
facility: The Biomedical Research Foundation of the Academy Athens
city: Genova
country: Italy
facility: University Hospital Genova
city: Milan
country: Italy
facility: Multi Medica, Care and Research Institute
city: Rome
country: Italy
facility: Casilino Hospital Rome
city: Turin
country: Italy
facility: University Hospital Turin
city: Białystok
country: Poland
facility: University of Bialystok
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Kraków
country: Poland
facility: Jagellonian University Medical College
city: Lublin
country: Poland
facility: University of Lublin
city: Toruniak
country: Poland
facility: Nicolaus Copernicus University
city: Warsaw
country: Poland
facility: National Institute of Cardiology
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz-CHLO
city: Lisbon
country: Portugal
facility: Hospital do Espirito Santo
city: Lisbon
country: Portugal
facility: Hospital Santa Maria-CHULN/FMUL
Study officials:
affiliation: Tampere University
name: Reijo Laaksonen, MD, PhD
role: STUDY_DIRECTOR
References: