Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:30 AM
Study NCT ID:
NCT07364058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Platelet-derived GARP in Atherosclerotic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D058226', 'term': 'Plaque, Atherosclerotic'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006650', 'term': 'Histocompatibility Testing'}, {'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The plaques extracted from carotid or femoral endarterectomy will be used or all analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-01-15', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GARP Expression in Platelets', 'timeFrame': 'Throughout the entire study, approximately during 3 years', 'description': 'The number of cells/area expressing the GARP protein will be assessed'}], 'secondaryOutcomes': [{'measure': 'GARP Expression T Regulating Cells', 'timeFrame': 'Throughout the entire study, approximately during 3 years', 'description': 'The number of cells expressing GARP will be assessed as a number of cells / area'}, {'measure': 'GARP Expression General', 'timeFrame': 'Throughout the entire study, approximately during 3 years', 'description': 'The type of cells expressing GARP will be assessed as a number of cells / area'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atheroma', 'Atherosclerosis', 'GARP', 'LRRC32'], 'conditions': ['Atheroma; Carotid Artery', 'Atheromatosis']}, 'descriptionModule': {'briefSummary': 'The leading cause of death is cardiovascular diseases in occidental countries. Of those, atherosclerosis is the major contributor to this burden being notably responsible for strokes and myocardial infarctions. The genesis of atherosclerosis is linked to both lipid accumulation and inflammation in the vascular wall of major arteries. One of the major pathways of inflammation is the TGF-beta axis which is at least partially regulated by the GARP protein. It has been investigated mostly in cancer biology but data in cardiovascular disease is lacking. Thus, the investigators aim to characterize the contribution of this protein by investigating its expression in tissue from patients with atherosclerosis, the carotid or femoral plaque representing a good source of residual material adequate for research purpose. The main cells expressing the GARP protein are the platelets and the T regulating cells which will be the main focus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will comprise patients undergoing femoral or carotid endarterectomy in our tertiary care center (Cliniques Universitaires Saint-Luc) for atherosclerotic disease who do not meet exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years\n* Able to give informed consent\n* Undergoing carotid or femoral endarterectomy\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Pregnant\n* Dialysis\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT07364058', 'acronym': 'CAPGAD', 'briefTitle': 'Assessment of Platelet-derived GARP in Atherosclerotic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Université Catholique de Louvain'}, 'officialTitle': 'Assessment of Platelet-derived GARP in Atherosclerotic Disease', 'orgStudyIdInfo': {'id': 'CAPGAD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endarterectomy population', 'description': 'This group includes patients with significant atherosclerotic burden justifying a surgical intervention of carotid or femoral endarterectomy.', 'interventionNames': ['Other: Tissue sample and data collection']}], 'interventions': [{'name': 'Tissue sample and data collection', 'type': 'OTHER', 'description': 'Tissue sample and data collection', 'armGroupLabels': ['Endarterectomy population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'contacts': [{'name': 'Louis Charki, Medical Degree', 'role': 'CONTACT', 'email': 'louis.charki@uclouvain.be', 'phone': '+3224362014'}, {'name': 'Christophe Beauloye, Medical Degree', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Louis Charki, Medical Degree', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maxime Elens, Medical Degree', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Louis Charki, Medical Degree', 'role': 'CONTACT', 'email': 'louis.charki@uclouvain.be', 'phone': '+3224362014'}], 'overallOfficials': [{'name': 'Christophe Beauloye, Medical Degree', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Catholique de Louvain', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds National de la Recherche Scientifique', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}