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NCT Number: NCT06526013

Cholesterol Self-testing in Patients Post Acute Coronary Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic of cardiology University clinic Leipzig

Leipzig, Saxony, 04103, Germany

Location status: Recruiting

Location contact

Irina Müller-Kozarez, Dr.med

CONTACT

[email protected]

03419711732

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholesterol self-measurement

Other

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.

Primary outcomes

  1. percentage value LDL-Cholesterol reduction in comparison to baseline

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Irina Mueller-Kozarez, Dr.med

CONTACT

[email protected]

03419711732

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Acronym: C-Check

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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