Impact of Prompt Medication Adjustment and Intensive Follow-up on Achieving Lipid Targets in Patients Undergoing Carotid Endarterectomy
| Registry | NCT07064135, acronym IMACS |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 50 (Estimated) |
| Sponsor | Barmherzige Brüder Linz (Other); collaborators: Johannes Kepler University of Linz |
| Conditions | Dyslipidaemias, Carotid Artery Stenoses |
| Interventions | Prompt Medication Adjustment and Intensive Follow-up, Standard Care (Behavioral, other) |
| Dates | start 2025-08-04 (estimated), primary completion 2026-06-01 (estimated), completion 2026-12-01 (estimated), first posted 2025-07-14, last updated 2025-08-07 |
| Locations | 1 site in Austria |
Related Papers Related Patents Related Grants Related Experts
All trials for Dyslipidaemias All trials for Carotid Artery Stenoses All trials of Prompt Medication Adjustment and Intensive Follow-up All trials of Standard Care
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intensive Follow-up | Experimental | Behavioral: Prompt Medication Adjustment and Intensive Follow-up | Participants in this arm receive prompt adjustment of lipid-lowering medication to achieve target LDL-C levels, combined with intensive follow-up visits and laboratory monitoring 6-8 weeks post-surgery to optimize lipid management. |
| Standard Care | Active comparator | Other: Standard Care | Participants in this arm receive standard postoperative care according to current guidelines, including routine follow-up and lipid management without additional early intervention or intensive monitoring. |
Sex: All, ages: 18 Years to any
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Konventhospital Barmherzige Brüder | Linz, Upper Austria | Austria |