Cholesterol Self-testing in Patients Post Acute Coronary Syndrome

Not Applicable

Recruiting

• Conditions: Acute Coronary Syndrome; LDL Hyperlipoproteinemia; Therapeutic Adherence; Prevention
• Interventions: Other: Cholesterol self-measurement

• Registration Number: NCT06526013
• Lead Sponsor: University of Leipzig

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.

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-29
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholesterol self-measurement	Cholesterol self-measurement	Training patients for self-monitoring of cholesterol, with independent monthly measurements and reporting of results to the study team, followed by prompt therapy adjustments

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Clinic of cardiology University clinic Leipzig; 🇩🇪 Leipzig, Saxony, Germany