Cholesterol Self-testing in Patients Post Acute Coronary Syndrome

NCT06526013 | Recruiting

• 1 other identifier: BGAAF-2593
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Prevention; LDL Hyperlipoproteinemia; Therapeutic Adherence

Keywords

Acute Coronary Syndrome; Dyslipidemia; Statin; Lipid lowering therapy; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• percentage value LDL-Cholesterol reduction in comparison to baseline

  Compare the change in value of LDL-Cholesterol with additional monthly self measurement of parameters after 6 months versus baseline and the control group.

  6 months

Study Arms (2)

Standard of care

NO INTERVENTION

Usual care according to current procedure (in patients with post acute coronary syndrome) regarding LDL target level adjustment

Cholesterol self-measurement

EXPERIMENTAL

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

Other: Cholesterol self-measurement

Interventions

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.

Cholesterol self-measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients with acute coronary syndrome in the last 6 months and not having reached the LDL target value
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

Clinic of cardiology University clinic Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Related Publications (17)

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  PMID: 31504418 BACKGROUND

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• Cholesterol Treatment Trialists' (CTT) Collaborators; Mihaylova B, Emberson J, Blackwell L, Keech A, Simes J, Barnes EH, Voysey M, Gray A, Collins R, Baigent C. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet. 2012 Aug 11;380(9841):581-90. doi: 10.1016/S0140-6736(12)60367-5. Epub 2012 May 17.

  PMID: 22607822 BACKGROUND

• Silverman MG, Ference BA, Im K, Wiviott SD, Giugliano RP, Grundy SM, Braunwald E, Sabatine MS. Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions: A Systematic Review and Meta-analysis. JAMA. 2016 Sep 27;316(12):1289-97. doi: 10.1001/jama.2016.13985.

  PMID: 27673306 BACKGROUND

• Kotseva K, De Backer G, De Bacquer D, Ryden L, Hoes A, Grobbee D, Maggioni A, Marques-Vidal P, Jennings C, Abreu A, Aguiar C, Badariene J, Bruthans J, Castro Conde A, Cifkova R, Crowley J, Davletov K, Deckers J, De Smedt D, De Sutter J, Dilic M, Dolzhenko M, Dzerve V, Erglis A, Fras Z, Gaita D, Gotcheva N, Heuschmann P, Hasan-Ali H, Jankowski P, Lalic N, Lehto S, Lovic D, Mancas S, Mellbin L, Milicic D, Mirrakhimov E, Oganov R, Pogosova N, Reiner Z, Stoerk S, Tokgozoglu L, Tsioufis C, Vulic D, Wood D; EUROASPIRE Investigators*. Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: Results from the European Society of Cardiology ESC-EORP EUROASPIRE V registry. Eur J Prev Cardiol. 2019 May;26(8):824-835. doi: 10.1177/2047487318825350. Epub 2019 Feb 10.

  PMID: 30739508 BACKGROUND

• Ray KK, Molemans B, Schoonen WM, Giovas P, Bray S, Kiru G, Murphy J, Banach M, De Servi S, Gaita D, Gouni-Berthold I, Hovingh GK, Jozwiak JJ, Jukema JW, Kiss RG, Kownator S, Iversen HK, Maher V, Masana L, Parkhomenko A, Peeters A, Clifford P, Raslova K, Siostrzonek P, Romeo S, Tousoulis D, Vlachopoulos C, Vrablik M, Catapano AL, Poulter NR; DA VINCI study. EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care: the DA VINCI study. Eur J Prev Cardiol. 2021 Sep 20;28(11):1279-1289. doi: 10.1093/eurjpc/zwaa047.

  PMID: 33580789 BACKGROUND

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  PMID: 36858065 BACKGROUND

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MeSH Terms

Conditions

Acute Coronary Syndrome; Treatment Adherence and Compliance; Dyslipidemias; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Health Behavior; Behavior; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ulrich Laufs, Professor

  University Clinik, Clinic for Cardiology Leipzig

  STUDY CHAIR

Central Study Contacts

Irina Mueller-Kozarez, Dr.med

CONTACT

03419711732; irina.mueller-kozarez@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 30, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)