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ClinicalTrials.gov ID

NCT04433052

Lead Sponsor

Tampere UniversityOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

12,000Estimated

Last Update Posted

Jun 12, 2023Actual

Start Date

Feb 1, 2023Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

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

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.

• Coronary Heart Disease

• personalised prevention program (PPP)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Tampere UniversityOTHER

Kristina.Hotakainen@mehilainen.fi