Improved Medication and Care to Achieve Lipid Targets After Carotid Surgery (IMACS)

Barmherzige Brüder Linz

Status: Not yet enrolling

Conditions: Dyslipidaemias; Carotid Artery Stenoses

Treatments: Behavioral: Prompt Medication Adjustment and Intensive Follow-up; Other: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07064135

IMACS-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Intensive Follow-up

Experimental group

Description:

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.

Treatment:

Behavioral: Prompt Medication Adjustment and Intensive Follow-up

Standard Care

Active Comparator group

Description:

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.

Treatment:

Other: Standard Care