DyslipidaemiasIMACSNCT07064135
Improved Medication and Care to Achieve Lipid Targets After Carotid Surgery
A study testing Prompt Medication Adjustment and Intensive Follow-up in people with Dyslipidaemias and Carotid Artery Stenoses, run by Barmherzige Brüder Linz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidaemias, Carotid Artery Stenoses
- What is being tested?
- Prompt Medication Adjustment and Intensive Follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 4 Aug 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >17 years
- Diagnosed carotid artery stenosis
- Planned carotid endarterectomy
- LDL cholesterol >55 mg/dL
- Willingness to participate, documented by written informed consent
Who cannot join
- Ongoing treatment with PCSK9 inhibitors
- Carotid surgery for reasons other than stenosis (e.g., traumatic injury)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Konventhospital Barmherzige Brüder
Linz, Upper Austria, 4020
Martina Gojevic, B.Sc., +43 732 7897 26311, martina.gojevic@bblinz.at
Rainer Hintenberger, MD, +43 732 7897 26350, rainer.hintenberger@bblinz.at
About this study
Official title: Impact of Prompt Medication Adjustment and Intensive Follow-up on Achieving Lipid Targets in Patients Undergoing Carotid Endarterectomy
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.
Read the 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.
- Conditions
- Dyslipidaemias, Carotid Artery Stenoses
- Being tested
- Prompt Medication Adjustment and Intensive Follow-up, Standard Care
- Keywords
- LDL-C lowering, Carotid Endarterectomy, Statins, Lipid Management, Secondary Prevention
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prompt Medication Adjustment and Intensive Follow-upBehavioural
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.
Standard CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Follow-up | Experimental | 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. Receives: Behavioral: Prompt Medication Adjustment and Intensive Follow-up |
| Standard Care | Active comparator | 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. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving the LDL-C target of <55 mg/dL
Measured: 12-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start4 Aug 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidaemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group RCT
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barmherzige Brüder Linz
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Kepler University of Linz
- Responsible party
- Principal investigator, Rainer Hintenberger, Barmherzige Brüder Linz
- Investigators
- Martin Clodi, Professor, MD, Study director, Konventspital Barmherzige Brüder LinzJuergen Falkensammer, Associate Professor, MD, Study chair, Konventspital Barmherzige Brüder Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064135
- Sponsor's protocol ID
- IMACS-2025
- Acronym
- IMACS
- Status last verified
- Aug 2025
- First submitted
- 3 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data (IPD) has not yet been determined. Sharing may be considered in the future depending on ethical approval, participant consent, and data protection regulations.