New Technologies for Intensive Prevention Programs - NET-IPP

Study Overview
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Brief Summary
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In a randomized trial patients hospitalized for myocardial infarction are prospectively enrolled and assigned to either a web-based intensive prevention program or usual care (1 : 1 randomization). The web-based program includes telemetric transmission of data on cardiocascular risk factors (physical activity, blood pressure, body weight) by patients to the study center, e-learning modules by the study center and repetitive electronic contacts by e-mails and apps between a prevention assistant and the patient. In addition, genetic risk on cardiovascular events will be assessed in all patients of the intervention group by a polygenetic risk score (PRS). Patients of the intervention group are randomly assigned to disclosure of genetic risk vs. no disclosure. The study hypothesis is that disclosure of genetic risk improves cardiovascular risk factor control by increased patient motivation.

Official Title
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New Technologies for Intensive Prevention Programs - NET-IPP

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: Web-based prevention program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalization due to acute myocardial infarction (ST-elevation or non-ST-elevation myocardial infarction) defined according to valid international guidelines Access to internet and consent to participate in a web-based prevention program Consent for genetic risk assessment for cardiovascular events and risk disclosure according to randomization Exclusion Criteria: Patient refusal or inability to give informed consent Hemodynamically significant valvular heart disease Exercise limitations due to clinical conditions not related to CAD (such as severe orthopedic disorders,..) Any major non-cardiac condition that would adversely affect survival during the duration of the study (such as cancer with prognosis < 2 years,..) Inability to cooperate with the protocol, including longterm follow-up Chronic drug and alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Web-based prevention program<br>Patients after myocardial infarction participate in a 12-months program with telemetric risk factor control, e-learning and E-Mail/App-contacts. In a substudy patients are further randomly assigned to disclosure of genetic risk vs. no disclosure. | Behavioral: Web-based prevention program<br>* Telemetric control of risk factors, e-learning, contacts by e-mails/apps. If no response telephone calls. In a substudy evaluation of disclosure of genetic risk.<br>|
| No Intervention: Usual Care<br>Patients after myocardial infarction are treated following the standard of care (clinical practice as offered by general practitioners, cardiologists, etc.). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants with serious adverse cardiovascular events | Serious adverse cardiovascular events are death (total and cardiovascular), resuscitations, strokes, myocardial infarctions, coronary revascularizations or hospitalizations due to unstable angina. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol | LDL cholesterol levels in mg per dl | 24 months | 
| Smoking status | Rate of participants who are active smokers in % | 24 months | 
| Physical inactivity | Caloric expenditure as assessed by IPAQ (International Physical Activity Questionnaire) in kilocalories per week | 24 months | 
| Blood pressure | Systolic and diastolic blood pressure measured in mmHg | 24 months | 
| Body mass index | Body mass index in kg/m² (calculated from body weight and height) | 24 months | 
| HbA1c | HbA1c levels in % | 24 months |