Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04433052
Status:
RECRUITING
Last Update Posted:
2023-06-12
First Post:
2020-06-04
Brief Title:
Clinical Value and Cost-effectiveness of a Personalized Prevention Program PPP in Patients With High Risk Stable CHD
Sponsor:
Tampere University
Organization:
Tampere University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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 ie 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 ie 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
PART A
To prospectively validate biomarkers in risk stratification among stable CHD subjects ie 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None