Carotid Artery Stenoses, Dyslipidaemias
Conditions
Keywords
LDL-C lowering, Carotid Endarterectomy, Statins, Lipid Management, Secondary Prevention
Brief summary
The goal of this clinical trial is to find out if patients who receive extra support stay on their cholesterol-lowering therapy and therefore have lower cholesterol levels after 4 months. Extra support means regular phone calls and close monitoring before and after carotid artery surgery. The study compares this approach to usual care. Participants will: Be randomly assigned to either standard care or extra support for 4 months. Receive cholesterol-lowering treatment and attend follow-up visits.
Detailed description
Cardiovascular risk factors are one of the leading causes of morbidity and mortality worldwide. Improving these often fails due to the lack of low-threshold access to specialized medical care. Especially in vascular surgery departments with multimorbid patients, optimizing the management of risk factors-particularly cholesterol-is essential. This exploratory randomized controlled pilot study aims to investigate the effects of pharmacological optimization of cholesterol management after carotid surgery with subsequent follow-up visits. For this purpose, 50 patients who are undergoing carotid surgery due to carotid stenosis will be randomized into two groups. In Group 1, 25 patients who have not reached the lipid target at the time of surgery will be included and re-evaluated regarding their therapy after 2 months and undergo another ambulatory cholesterol check after 4 months. In Group 2, 25 patients who also have not reached the lipid target at the time of surgery will be included and, after optimization of therapy during the hospital stay, will undergo an ambulatory cholesterol check after 4 months.
Interventions
BEHAVIORALPrompt Medication Adjustment and Intensive Follow-up
Participants receive prompt adjustment of lipid-lowering therapy perioperatively and 6-8 weeks after carotid endarterectomy to achieve guideline-recommended LDL-C targets, combined with intensive follow-up visits and laboratory monitoring. Intensive follow-up visits and laboratory monitoring of lipid parameters are performed at 6-8 weeks and again at 12-16 weeks postoperatively to optimize lipid management.
OTHERStandard Care
Participants receive standard postoperative care according to guidelines, including lipid management and routine follow-up without additional early intervention or intensive monitoring. Lipid parameters are assessed only once at 12-16 weeks postoperatively.
Sponsors
Johannes Kepler University of Linz
Barmherzige Brüder Linz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Two-arm, parallel-group RCT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>17 years * Diagnosed carotid artery stenosis * Planned carotid endarterectomy * LDL cholesterol \>55 mg/dL * Willingness to participate, documented by written informed consent
Exclusion criteria
* Ongoing treatment with PCSK9 inhibitors * Carotid surgery for reasons other than stenosis (e.g., traumatic injury)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving the LDL-C target of <55 mg/dL | 12-16 weeks |
Countries
Austria
Contacts
Primary ContactRainer Hintenberger, MD
Backup ContactMatthias Heinzl, MD
Outcome results
None listed