Germany on Target Registry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDeutsche Gesellschaft für Lipidologie e. V. (DGFL) - Lipid-Liga
About this trial
Germany on Target Registry (DaZiR) is a prospective, Germany-wide patient registry designed to assess lipid management and low-density lipoprotein cholesterol ( LDL-C) target attainment in adults following acute myocardial infarction (STEMI or NSTEMI).
Eligible patients are informed about the registry by treating physicians or their medical teams and receive an individual access link or QR code. Following electronic informed consent and registration, participants provide clinical and follow-up information through the brite™ platform.
Clinical data, including LDL-C values and lipid-lowering treatment, can be entered by the participants or obtained from uploaded medical documents. The platform enables participants to follow the course of their LDL-C values and provides reminders for scheduled follow-up data collection.
Medical treatment is determined independently by the treating physicians as part of routine clinical care and is not assigned by the registry. The registry aims to assess LDL-C target attainment over time, changes in lipid-lowering treatment, treatment adherence and cardiovascular outcomes following myocardial infarction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Diagnosis of acute ST-elevation myocardial infarction (STEMI) or non-ST- elevation myocardial infarction (NSTEMI)
Provision of informed consent for participation in the registry
Disqualifiers
No informed consent for participation in the registry
Trial population
Adults aged 18 years or older following an acute ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) treated in Germany. Potential participants are identified and informed about the registry by physicians or medical institutions and voluntarily enroll using an individual access link or QR code.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No study-assigned intervention
Other interventionParticipants receive medical care according to routine clinical practice. The registry does not prescribe or assign lipid-lowering treatment. Lipid-lowering therapies and subsequent treatment changes are documented as part of the observational data collection.
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: Patients following acute myocardial infarction1 intervention
Trial outcomes
Primary outcomes
1
LDL-C target attainment
The primary endpoint of the study/registry is the achievement and maintenance of the LDL-C target level recommended by the current ESC/EAS guidelines for high-risk cardiovascular patients during the follow-up period. Assessment is based on documented LDL-C measurements taken at specified time points (after 6 weeks, 3, 6, and 12 months, as well as during the subsequent long-term follow-up).
Time frame
12 monthsSecondary outcomes
1
Absolute change in LDL cholesterol
Absolute change in LDL cholesterol concentration from the baseline or discharge value to the predefined follow-up assessments. Unit: mg/dL
Time frame
Baseline to 60 month2
Percentage change in LDL cholesterol
Percentage change in LDL cholesterol concentration from the baseline or discharge value to the predefined follow-up assessments. Unit: %
Time frame
Baseline to 60 Month3
Body weight
Body weight documented for registry participants. Unit: kg
Time frame
Baseline4
Body height
Body height documented for registry participants. Unit: cm
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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