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Intensive Lipid-Lowering Therapy guided by a cloud-based Software System (CLIMEDO GmbH) improves (European Society of Cardiolofgy/European Atherosclerosis Society) ESC/EAS-guideline recommended LDL-cholesterol target attainment and adherence in patients with ST-Elevation Myocardial (STEMI) and Non-ST-Elevation Myocardial Infarctions (NSTEMI).
Patients admitted to the Jena University Hospital (UKS) and 9 other University hospitals in Germany with an ST-elevation or Non-ST-elevation myocardial infarction (STEMI) will be randomized to standard care or a software-based tool (CLIMEDO GmbH) to monitor low-density cholesterol (LDL-C) levels and close follow-ups to achieve ESC/EAS-guideline recommended LDL-C goals.
In this multi-center, prospective, randomized, interventional trial we propose that using a cloud-based software system (CLIMEDO GmbH) is superior to standard care in terms of LDL-C target attainment at 6 months and adherence over a time period of 12 months.
In the software group LDL-C levels will be monitored on admission, after 1,6, 12, 16, 20 weeks and after 6, 12 and 24 months. In the standard care group patients' LDL-C levels will be determined on admission after 6, 12 and 24 months. The primary endpoint is LDL-C target attainment at 6 months in both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cloud-based software | Active Comparator | cloud-based software system (CLIMEDO GmbH) will support patients in ESC/EAS LDL-C target attainment (< 55mg/dl/1.4 mol/L) |
|
| Standard Care | Placebo Comparator | Patients will be treated by general practitioners (GPs) after hospital discharge. The discharge letter will recommend ESC/EAS dyslipidemia LDL-cholesterol targets (< 55mg/dl/1.4 mol/L) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran | Drug | dietary advice for low cholesterol food |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C | LDL-C target attainment (ESC/EAS dyslipidemia guidelines) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| side-effects of lipid lowering therapy | muscle pain, hair loss, dizziness, joint pain, depression | 6 months |
| adherence to LLT | regular LLT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oliver Weingärter, MD | Contact | 036419324521 | oliver.weingaertner@med.uni-jena.de | |
| Franz Härtel, MD | Contact | franz.haertel@med.uni-jena.de |
| Name | Affiliation | Role |
|---|---|---|
| Oliver Weingärtner, MD | Jena University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Jena | Jena | Thuringia | 07747 | Germany |
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randomized trial to compare a cloud-based software system with standard care
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|
| 12 months |
| Universitätsmedizin Berlin | Berlin | Germany |
| Universitätsklinikum Dresden | Dresden | Germany |
| Universitätsklinikum Essen | Essen | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Germany |
| Universitätsklinikum Halle | Halle | Germany |
| Universitätsklinikum des Saarlandes | Homburg | Germany |
| Universitätsklinikum Leipzig | Leipzig | Germany |
|
| Universitätsklinikum Regensburg | Regensburg | Germany |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D000069438 | Ezetimibe |
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
| C577155 | evolocumab |
| C571059 | alirocumab |
| C585830 | ALN-PCS |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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