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

June 9, 2023 updated by: Reijo Laaksonen, Tampere University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Finland
  • Germany
      • Berlin, Germany
        • Not yet recruiting
        • Klinik am See
        • Contact:
          • Heinz Völler, MD, PhD
      • Frankfurt, Germany
        • Withdrawn
        • CCV-MVZ
      • Mannheim, Germany
        • Not yet recruiting
        • Heidelberg University
        • Contact:
          • Winfried März, MD, PhD
      • München, Germany
        • Not yet recruiting
        • Technise Universität Munchen
        • Contact:
          • Martin Halle, MD, PhD
      • Ulm, Germany
        • Not yet recruiting
        • Herzklinik Ulm
        • Contact:
          • Ralf Birkemeyer, MD, PhD
  • Greece
      • Athens, Greece
        • Not yet recruiting
        • Hellenic Red Cross Hospital
        • Contact:
          • Nikolaos Bourmpoulis, MD, PhD
      • Athens, Greece
        • Not yet recruiting
        • Konstantopoulio Hospital
        • Contact:
          • Patsilinakos Sotirios, MD, PhD
      • Athens, Greece
        • Not yet recruiting
        • Sismanoglion Hospital
        • Contact:
          • Dimitrios Sionis, MD, PhD
      • Athens, Greece
        • Not yet recruiting
        • The Biomedical Research Foundation of the Academy Athens
        • Contact:
  • Italy
      • Genova, Italy
        • Not yet recruiting
        • University Hospital Genova
        • Contact:
      • Milan, Italy
        • Not yet recruiting
        • Multi Medica, Care and Research Institute
        • Contact:
          • Roberto FE Pedretti, MD, PhD
      • Rome, Italy
        • Not yet recruiting
        • Casilino Hospital Rome
        • Contact:
          • Leonardo Calo, MD, PhD
      • Turin, Italy
  • Poland
      • Białystok, Poland
        • Not yet recruiting
        • University of Bialystok
        • Contact:
          • Karol Kaminski, MD, PhD
      • Katowice, Poland
        • Not yet recruiting
        • Medical University of Silesia
        • Contact:
      • Kraków, Poland
        • Not yet recruiting
        • Jagellonian University Medical College
        • Contact:
      • Lublin, Poland
        • Not yet recruiting
        • University of Lublin
        • Contact:
          • Andrzej Wysokinski, MD, PhD
      • Toruniak, Poland
        • Not yet recruiting
        • Nicolaus Copernicus University
        • Contact:
          • Aldona Kubica, MD, PhD
      • Warsaw, Poland
        • Not yet recruiting
        • National Institute of Cardiology
        • Contact:
          • Rafal Dabrowski, MD, PhD
  • Portugal
      • Carnaxide, Portugal
        • Not yet recruiting
        • Hospital de Santa Cruz-CHLO
        • Contact:
          • Miguel Mendes, MD, PhD
      • Lisbon, Portugal
        • Not yet recruiting
        • Hospital do Espirito Santo
        • Contact:
          • Lino Patricio, MD, PhD
      • Lisbon, Portugal
        • Not yet recruiting
        • Hospital Santa Maria-CHULN/FMUL
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Personalised prevention program (PPP)
Participants will be invited to return to the study site six times over a three year period to receive lifestyle coaching and exercise prescriptions. Eupropean Society of Cardiology/European Association of Preventive Cardiology (ESC/EAPC) -designed lifestyle counselling will be partially delivered by novel smartphone applications. Participants will also receive pharmaceutical treatment according to the ESC guideline for chronic coronary syndromes.
Behavioral: personalised prevention program (PPP)
Study subjects in the PPP arm will be invited to return to the study site six times over a three-year period (at V2/start of the study, V3/mo2, V4/mo6, V5/mo12, V6/mo18 and V7/mo36) to receive lifestyle coaching and exercise prescriptions led by a delegated member of the site staff and supervised by the investigator. Information on drug treatment will also be given by the investigator. These activities will be assisted by digital tools specifically designed for this study, the CoroPrevention Tool Suite.
No Intervention: Usual care (UC)

Participants will be referred back to usual care provided by their treating physicians. It is anticipated that physicians will treat these participants according to local usual medical practices. Patients randomized to UC group will not receive any treatment recommendations nor restrictions by the study investigators or nurses.

Randomized UC patients are invited to site visits twice over a three year period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 3 years follow-up
• The time from randomisation to the occurrence of the first CV event included in the composite endpoint of the study (CV death, nonfatal MI, HF events) over 3 years follow-up.
3 years follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the difference between PPP arm to the UC arm in
Time Frame: 3 years follow-up
o The times from randomisation to the occurrence of the specific items included in the composite endpoint (CV death, nonfatal MI, HF event) over 3 years follow-up
3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
Time Frame: 3 years follow-up
o The times from randomisation to the occurrence of secondary CV events (unstable angina, stroke and coronary revascularisations excluding those elective revascularisations that have been planned prior to randomisation)
3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
Time Frame: 3 years follow-up
o Treatment adherence; measured by compliance laboratory assessments and in the PPP group, also with activity reports
3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
Time Frame: 3 years follow-up
All-cause mortality
3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
Time Frame: 3 years follow-up
Incidence of additional clinical endpoints: diabetes mellitus type 2 (DM2), chronic kidney disease (CKD), peripheral artery disease (PAD) and hypertension
3 years follow-up
To evaluate the health economic value of the PPP
Time Frame: 3 years follow-up
o A cost-effectiveness analysis of PPP versus UC will be undertaken, based on evidence from the randomised clinical trial (RCT) portion of the study, using within-trial analysis and long-term cost-effectiveness modelling for the six countries participating in the CoroPrevention trial: Finland, Poland, Greece, Portugal, Italy, and Germany.
3 years follow-up
• To prospectively study associations (in all enrolled subjects) between separate risk biomarkers (CERT2, hs-troponin , proBNP, Cystatin C) or their score (CoroPredict) and
Time Frame: 3 years follow-up
  • Primary composite CV event (CV death, MI, HF events)
  • Specific CV events (CV death, nonfatal MI, HF events) separately
  • Specific secondary CV events (unstable angina, stroke, coronary revascularisations)
  • Incidence of DM2, CKD, PAD and hypertension
3 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tampere University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Reijo Laaksonen, MD, PhD, Tampere University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPP-2020-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

EU open access policy

IPD Sharing Time Frame

opens 2 years after last study patient visit, open for 18 years until IPD deletion

IPD Sharing Access Criteria

Steering Committee decision, application needed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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