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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prompt Medication Adjustment and Intensive Follow-up on Achieving Lipid Targets in Patients Undergoing Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT07064135
- Acronym / sponsor ID
- IMACS / IMACS-2025
- Conditions
- Dyslipidaemias, Carotid Artery Stenoses
- Keywords
- LDL-C lowering, Carotid Endarterectomy, Statins, Lipid Management, Secondary Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Barmherzige Brüder LinzUniversity, hospital or other
- Collaborators
- Johannes Kepler University of Linz
- Study start
- 4 Aug 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group RCT
| Arm | Type | Receives |
|---|---|---|
| Intensive Follow-up | Experimental | Behavioral: Prompt Medication Adjustment and Intensive Follow-upParticipants 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 CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >17 years
- Diagnosed carotid artery stenosis
- Planned carotid endarterectomy
- LDL cholesterol >55 mg/dL
- Willingness to participate, documented by written informed consent
Key exclusion criteria (2 listed)
- Ongoing treatment with PCSK9 inhibitors
- Carotid surgery for reasons other than stenosis (e.g., traumatic injury)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prompt Medication Adjustment and Intensive Follow-upParticipants 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. | Behavioural | Intensive Follow-up |
| Standard CareParticipants 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. | Other | Standard Care |
Primary outcome
Proportion of patients achieving the LDL-C target of <55 mg/dL
Time frame: 12-16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: 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.
Related trials for Dyslipidaemias
RecruitingObservational study
Assessment of Compliance With European and French Guidelines for the Management of Dyslipidaemias
Patient With Dyslipidemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Clodi, Professor, MD study director
Konventspital Barmherzige Brüder Linz
Juergen Falkensammer, Associate Professor, MD study chair
Konventspital Barmherzige Brüder Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rainer Hintenberger, MD (+43 676 4295509, rainer.hintenberger@bblinz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving the LDL-C target of <55 mg/dL (time frame: 12-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.