Acute Coronary Syndrome, LDL Hyperlipoproteinemia, Prevention, Therapeutic Adherence
Conditions
Keywords
Acute Coronary Syndrome, Dyslipidemia, Statin, Lipid lowering therapy, Cardiovascular disease
Brief summary
The pharmacological reduction of LDL-C lowers cardiovascular risk and is therefore a priority in cardiovascular secondary prevention. The achievement of LDL-C target levels in Germany, Europe, and worldwide is inadequate, despite a wide array of lipid-lowering medications. Only a small proportion of post-myocardial infarction patients reach their LDL-C target range within a year. There is a significant need for new strategies to improve LDL-C target achievement and thereby reduce the occurrence of secondary cardiovascular events. The aim of the study is to establish a basis for improving prevention by achieving the target LDL level effectively and quickly in patients with high and very high cardiovascular risk profiles.
Detailed description
In this randomized study, the investigators aim to investigate whether additional self-monitoring of cholesterol values by patients leads to more effective LDL reduction and quicker achievement of the target LDL range versus usual care. This study systematically and prospectively examines the benefits of self-monitoring and control of cholesterol levels for the first time. The patients in the intervention arm will receive a device for self-measurement of cholesterol values and will be trained in its use. These patients will independently measure their cholesterol levels monthly using capillary blood tests and report the results to the study physicians, who will then adjust the therapy accordingly. The control arm is treated according to local standards, which includes control of the cholesterol values twice a year at the visit in out-patient clinic. Patients in both study arms will be followed up for at least 12 months.
Interventions
OTHERCholesterol self-measurement
Patients will be trained to use a device to self-measurement of cholesterol-values monthly. After the measurement they will report their results to study team for ajusting the therapy.
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
After randomization into the intervention arm versus control, patients in the intervention group will receive a device for self-measurement and will be trained in its use. Subsequently, these patients will independently measure their cholesterol levels monthly using capillary blood tests and report the results to the study physicians, who will then adjust the therapy accordingly. The control group will attend scheduled visits at months 6 and 12, where medication adjustments can be made, as has been done in the outpatient clinic up to now
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Patients with acute coronary syndrome in the last 6 months and not having reached the LDL target value * Signed informed consent
Exclusion criteria
* Persons unable to understand the study * Persons unable or unwilling to perform self-measurements * Persons unable or unwilling to undergo additional cholesterol-lowering therapy to reach the LDL target * Pre-menopausal women without contraception * Use of experimental drugs or investigational products within 30 days prior to screening * Employees or contractors of the institution conducting the study or family members of the Principal Investigator, Co-Investigator, or financial supporter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage value LDL-Cholesterol reduction in comparison to baseline | 6 months | Compare the change in value of LDL-Cholesterol with additional monthly self measurement of parameters after 6 months versus baseline and the control group. |
Countries
Germany
Contacts
Primary ContactIrina Mueller-Kozarez, Dr.med
Outcome results
None listed