Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD

Last updated: June 9, 2023
Sponsor: Tampere University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Coronary Artery Disease

Chest Pain

Treatment

personalised prevention program (PPP)

Clinical Study ID

NCT04433052
CPP-2020-1
  • Ages 30-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 computerisedtomography (CT) performed within the preceding one year (from enrolment visit). or Myocardial infarction (type I, II) during the preceding year.

Exclusion

Eligible study subjects must not meet any of the following exclusion criteria:

  1. Hospitalisation for acute coronary syndrome, myocardial infarction, stroke, coronaryrevascularisation or acute heart failure within the preceding one month (30 days).These subjects can be enrolled after a one-month stabilisation period, which beginsfrom the time of the event.
  2. Subjects with NYHA class III-IV heart failure i.e. marked limitation in activity dueto 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 asrheumatoid arthritis, neurological or orthopaedic diseases.
  6. Known aplastic or haemolytic anaemia.
  7. Concomitant non-coronary disease, such as malignancy that limits life expectancy toless 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 allstudy procedures and use a smartphone application.

Study Design

Total Participants: 12000
Treatment Group(s): 1
Primary Treatment: personalised prevention program (PPP)
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Helsinki University Hospital

    Helsinki,
    Finland

    Active - Recruiting

  • Mehiläinen

    Helsinki,
    Finland

    Active - Recruiting

  • North Carelia Central Hospital

    Joensuu,
    Finland

    Site Not Available

  • Kuopio University Hospital

    Kuopio,
    Finland

    Site Not Available

  • Oulu University Hospital

    Oulu,
    Finland

    Active - Recruiting

  • Klinik am See

    Berlin,
    Germany

    Site Not Available

  • CCV-MVZ

    Frankfurt,
    Germany

    Site Not Available

  • Heidelberg University

    Mannheim,
    Germany

    Site Not Available

  • Technise Universität Munchen

    München,
    Germany

    Site Not Available

  • Herzklinik Ulm

    Ulm,
    Germany

    Site Not Available

  • Hellenic Red Cross Hospital

    Athens,
    Greece

    Site Not Available

  • Konstantopoulio Hospital

    Athens,
    Greece

    Site Not Available

  • Sismanoglion Hospital

    Athens,
    Greece

    Site Not Available

  • The Biomedical Research Foundation of the Academy Athens

    Athens,
    Greece

    Site Not Available

  • University Hospital Genova

    Genova,
    Italy

    Site Not Available

  • Multi Medica, Care and Research Institute

    Milan,
    Italy

    Site Not Available

  • Casilino Hospital Rome

    Rome,
    Italy

    Site Not Available

  • University Hospital Turin

    Turin,
    Italy

    Site Not Available

  • University of Bialystok

    Białystok,
    Poland

    Site Not Available

  • Medical University of Silesia

    Katowice,
    Poland

    Site Not Available

  • Jagellonian University Medical College

    Kraków,
    Poland

    Site Not Available

  • University of Lublin

    Lublin,
    Poland

    Site Not Available

  • Nicolaus Copernicus University

    Toruniak,
    Poland

    Site Not Available

  • National Institute of Cardiology

    Warsaw,
    Poland

    Site Not Available

  • Hospital de Santa Cruz-CHLO

    Carnaxide,
    Portugal

    Site Not Available

  • Hospital Santa Maria-CHULN/FMUL

    Lisbon,
    Portugal

    Site Not Available

  • Hospital do Espirito Santo

    Lisbon,
    Portugal

    Site Not Available

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