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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-based prevention program | Active Comparator | 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. |
|
| Usual Care | No Intervention | Patients after myocardial infarction are treated following the standard of care (clinical practice as offered by general practitioners, cardiologists, etc.). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based prevention program | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to preventive medication | Rate of patients with lipid-lowering medication, antiplatelets (= aspirine, ticagrelor, prasugrel, clopidogrel) | 24 months |
| Assessment of quality of life | Point score of the European Quality of Life 5 Dimensions (EQ5D) Questionnaire - Visual Analogue Scale (VAS). The Scale ranges from 0 to 100, with 100 indicating the best Quality of Life and 0 indicating the worst Quality of Life |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Bremen | Bremen | 28277 | Germany |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| 24 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |