Clinical trial NCT05587621: Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)
Official title: "Intensive Lipid-Lowering Therapy Guided by a Cloud-based Software System (CLIMEDO GmbH) in Patients With ST-Elevation and Non-ST-Elevation Myocardial Infarctions" (Germany on Target)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Non-ST Elevation Myocardial Infarction
LDL-cholesterol
Keywords: STEMI, NSTEMI; LDL-C; target attainment
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized trial to compare a cloud-based software system with standard care
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients with ST- and Non-ST-elevation myocardial infarctions

Exclusion Criteria:

* patient without informed concent
* patients in cardiogenic shock
* patients with contraindication to lipid-lowering therapy
* patients on lipid-lowering medications on admission

Primary outcomes:
measure: LDL-C
timeFrame: 6 months
Secondary outcomes:
measure: side-effects of lipid lowering therapy
timeFrame: 6 months
measure: adherence to LLT
timeFrame: 12 months
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University Hospital Jena
state: Thuringia
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Halle
country: Germany
facility: Universitätsklinikum Halle
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
Study officials:
affiliation: Jena University Hospital
name: Oliver Weingärtner, MD
role: PRINCIPAL_INVESTIGATOR
References: