Reducing the Global Burden of Cardiovascular Disease, Part 1: The Epidemiology and Risk Factors.
Philip Joseph, Darryl Leong, Martin McKee...
https://pubmed.ncbi.nlm.nih.gov/28860318Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06526013
Cholesterol Self-testing in Patients Post Acute Coronary Syndrome
Led by University of Leipzig · Updated on 2024-08-01
200
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who have had an acute coronary syndrome to find better ways to lower LDL cholesterol, which is important for reducing the risk of further heart problems. Despite many cholesterol-lowering drugs, many patients do not reach their LDL target levels within a year, so this study aims to explore new strategies for quicker and more effective LDL reduction, especially in those with high cardiovascular risk. The study compares two groups: one receiving usual care with cholesterol levels checked twice a year in outpatient clinics, and another group trained to self-measure their cholesterol monthly using a special device. Patients in the self-monitoring group will report their monthly results to the study doctors, who will adjust treatment as needed. Both groups will be followed for at least 12 months to assess outcomes. Participants will have regular cholesterol tests and medical evaluations during the study. Researchers will measure the percentage reduction in LDL cholesterol after six months compared to baseline. The study monitors how quickly patients achieve their LDL targets and adjusts treatments accordingly, aiming to improve long-term cardiovascular prevention. The total participation time is at least one year.
CONDITIONS
Brief Title
Cholesterol Self-testing in Patients Post Acute Coronary Syndrome
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients with acute coronary syndrome in the last 6 months who have not reached the LDL target value
- Signed informed consent
You will not qualify if you...
- Unable to understand the study
- Unable or unwilling to perform self-measurements
- Unable or unwilling to undergo additional cholesterol-lowering therapy
- Pre-menopausal women without contraception
- Use of experimental drugs within 30 days prior to screening
- Employees, contractors, or family members of the study team or financial supporters
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - At least 12 months
Participants receive either usual care with cholesterol checks twice a year or training and monthly self-measurement of cholesterol with therapy adjustments based on results.
Monthly self-measurement for the experimental arm; biannual clinic visits for the standard care arm
Trial Site Locations
Total: 1 location
1
Clinic of cardiology University clinic Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
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Research Team
I
Irina Mueller-Kozarez, Dr.med
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel.
Brian A Ference, Henry N Ginsberg, Ian Graham...
https://pubmed.ncbi.nlm.nih.gov/284442902019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk.
François Mach, Colin Baigent, Alberico L Catapano...
https://pubmed.ncbi.nlm.nih.gov/31504418Efficacy and safety of LDL-lowering therapy among men and women: meta-analysis of individual data from 174,000 participants in 27 randomised trials.
Cholesterol Treatment Trialists' (CTT) Collaboration, Jordan Fulcher, Rachel O'Connell...
https://pubmed.ncbi.nlm.nih.gov/25579834The 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.
Cholesterol Treatment Trialists' (CTT) Collaborators, B Mihaylova, J Emberson...
https://pubmed.ncbi.nlm.nih.gov/22607822Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions: A Systematic Review and Meta-analysis.
Michael G Silverman, Brian A Ference, Kyungah Im...
https://pubmed.ncbi.nlm.nih.gov/27673306Lifestyle 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.
Kornelia Kotseva, Guy De Backer, Dirk De Bacquer...
https://pubmed.ncbi.nlm.nih.gov/30739508EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care: the DA VINCI study.
Kausik K Ray, Bart Molemans, W Marieke Schoonen...
https://pubmed.ncbi.nlm.nih.gov/33580789[Treatment and LDL cholesterol adjustment in patients with high and very high cardiovascular risk in Germany compared with Europe - data from the SANTORINI registry].
Paulina Elena Stürzebecher, Adrienn Tünnemann-Tarr, Katja Tuppatsch...
https://pubmed.ncbi.nlm.nih.gov/36858065Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins.
Kathleen M Fox, Ming-Hui Tai, Karel Kostev...
https://pubmed.ncbi.nlm.nih.gov/29273856