Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT07064135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improved Medication and Care to Achieve Lipid Targets After Carotid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm, parallel-group RCT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-07-03', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients achieving the LDL-C target of <55 mg/dL', 'timeFrame': '12-16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LDL-C lowering', 'Carotid Endarterectomy', 'Statins', 'Lipid Management', 'Secondary Prevention'], 'conditions': ['Dyslipidaemias', 'Carotid Artery Stenoses']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants will:\n\nBe randomly assigned to either standard care or extra support for 4 months. Receive cholesterol-lowering treatment and attend follow-up visits.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>17 years\n* Diagnosed carotid artery stenosis\n* Planned carotid endarterectomy\n* LDL cholesterol \\>55 mg/dL\n* Willingness to participate, documented by written informed consent\n\nExclusion Criteria:\n\n* Ongoing treatment with PCSK9 inhibitors\n* Carotid surgery for reasons other than stenosis (e.g., traumatic injury)'}, 'identificationModule': {'nctId': 'NCT07064135', 'acronym': 'IMACS', 'briefTitle': 'Improved Medication and Care to Achieve Lipid Targets After Carotid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Barmherzige Brüder Linz'}, 'officialTitle': 'Impact of Prompt Medication Adjustment and Intensive Follow-up on Achieving Lipid Targets in Patients Undergoing Carotid Endarterectomy', 'orgStudyIdInfo': {'id': 'IMACS-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive Follow-up', '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.', 'interventionNames': ['Behavioral: Prompt Medication Adjustment and Intensive Follow-up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', '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.', 'interventionNames': ['Other: Standard Care']}], 'interventions': [{'name': 'Prompt Medication Adjustment and Intensive Follow-up', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intensive Follow-up']}, {'name': 'Standard Care', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4020', 'city': 'Linz', 'state': 'Upper Austria', 'country': 'Austria', 'contacts': [{'name': 'Martina Gojevic, B.Sc.', 'role': 'CONTACT', 'email': 'martina.gojevic@bblinz.at', 'phone': '+43 732 7897 26311'}, {'name': 'Rainer Hintenberger, MD', 'role': 'CONTACT', 'email': 'rainer.hintenberger@bblinz.at', 'phone': '+43 732 7897 26350'}, {'name': 'Rainer Hintenberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matthias Heinzl, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Konventhospital Barmherzige Brüder', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}], 'centralContacts': [{'name': 'Rainer Hintenberger, MD', 'role': 'CONTACT', 'email': 'rainer.hintenberger@bblinz.at', 'phone': '+43 676 4295509'}, {'name': 'Matthias Heinzl, MD', 'role': 'CONTACT', 'email': 'matthias.heinzl@bblinz.at', 'phone': '+43 676 5206829'}], 'overallOfficials': [{'name': 'Martin Clodi, Professor, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Konventspital Barmherzige Brüder Linz'}, {'name': 'Juergen Falkensammer, Associate Professor, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Konventspital Barmherzige Brüder Linz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barmherzige Brüder Linz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johannes Kepler University of Linz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Physician, Department of Vascular Surgery', 'investigatorFullName': 'Rainer Hintenberger', 'investigatorAffiliation': 'Barmherzige Brüder Linz'}}}}