Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-29 @ 4:59 PM
Study NCT ID:
NCT05802706
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2023-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Biomechanical Study of Diseased Human Carotid, Femoral and Abdominal Aortic Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Arterial plaque tissue is retained following the routine endarterectomy procedure.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2023-03-24', 'studyFirstSubmitQcDate': '2023-03-24', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calcification feature classification', 'timeFrame': '10 years', 'description': 'Identification of particular calcification features of plaque tissue and their influence on mechanical properties which may help clarify the success of stenting in certain patient cohorts compared to others and elucidate the procedural risk of endovascular treatments in plaque with certain calcification types.'}, {'measure': 'Biomarker Analysis', 'timeFrame': '10 years', 'description': 'Identification of novel biomarkers of vascular calcification could potentially be used as a predictive tool to highlight those at greatest risk of adverse peri-operative events, to allow for tailored medical treatment approaches and to stream-line patient care and improve patient outcomes.'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular Health Critical Mass', 'timeFrame': '10 years', 'description': 'To build a critical mass in cardiovascular health, an area of strategic importance for healthcare in Ireland.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vascular Diseases']}, 'descriptionModule': {'briefSummary': 'This cross-sectional study aims to ascertain the mechanical properties of human carotid/femoral atherosclerotic plaque and abdominal aortic aneurysm tissue and correlate tissue mechanics with novel blood-based biomarkers of cardiovascular calcification.', 'detailedDescription': 'The study is a non-randomised, controlled, cross-sectional study of diseased human carotid, femoral and abdominal aortic tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients eligible for peripheral endarterectomy of the carotid/femoral artery or abdominal aortic aneurysm surgery to remove artery blockage will be invited to take part in this study with no restrictions on patient type.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with arterial plaque undergoing treatment where the plaque tissue will be surgically removed as per the usual peripheral endarterectomy procedure.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Patients that are unable to give informed consent.\n* Seriously ill/unconscious patients.'}, 'identificationModule': {'nctId': 'NCT05802706', 'briefTitle': 'The Biomechanical Study of Diseased Human Carotid, Femoral and Abdominal Aortic Tissue', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Limerick'}, 'officialTitle': 'The Biomechanical Study of Diseased Human Carotid, Femoral and Abdominal Aortic Tissue', 'orgStudyIdInfo': {'id': 'DVS008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention.', 'type': 'OTHER', 'description': 'No intervention.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Limerick', 'state': 'Limerick', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Fiona Leahy, MSc', 'role': 'CONTACT', 'email': 'fionac.leahy@hse.ie', 'phone': '061 301111'}], 'facility': 'University Hospital Limerick', 'geoPoint': {'lat': 52.66472, 'lon': -8.62306}}], 'centralContacts': [{'name': 'Fiona Leahy, MSc', 'role': 'CONTACT', 'email': 'fionac.leahy@hse.ie', 'phone': '061 301111'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Limerick', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CNM II Research', 'investigatorFullName': 'Fiona Leahy', 'investigatorAffiliation': 'University Hospital of Limerick'}}}}