Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT05774535
Status:
WITHDRAWN
Last Update Posted:
2025-10-02
First Post:
2023-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'C562732', 'term': 'Euthyroid Goiter'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-07', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Carotid Intima-Media Thickness (cIMT)', 'timeFrame': 'Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery', 'description': 'cIMT is a measurement of the thickness of tunica intima and tunica media, the innermost two layers of the wall of an artery. The measurement is made by external ultrasound according to the recommendation of the Joint Carotid Intima-Media Thickness and Plaque Area Measurement in Ultrasound for Cardiovascular/Stroke Risk Monitoring.'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of adverse events during periprocedural period', 'timeFrame': 'Within 30 days after the surgery', 'description': 'Incidence of death, major stroke, minor stroke, transient ischemic attack'}, {'measure': 'Cumulative incidence of adverse events during postprocedural period', 'timeFrame': 'Between 30 days after the surgery and 12 months after surgery', 'description': 'Incidence of death, major stroke, minor stroke, transient ischemic attack'}, {'measure': 'Change from baseline in lipid profile', 'timeFrame': 'Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery', 'description': 'Total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carotid intima-media thickness', 'cardiovascular disease', 'thyroid disease', 'carotid artery'], 'conditions': ['Plummer Disease', 'Multinodular Goiter', 'Graves Disease', 'Hyperthyroidism', 'Euthyroid Goiter', 'Thyroid Cancer', 'Basedow Disease']}, 'descriptionModule': {'briefSummary': 'The evaluation of carotid intima-media thickness (cIMT) has become a possible predictor of the future risk of cardiovascular diseases (CVD). Evidence to date shows that cIMT augmentation is correlated with the extent of atherosclerosis in the coronary arteries and with other risk factors for CVD. More recently, several studies have evaluated the association of cIMT with stroke, to determine whether this measure can also predict future cardiovascular events.\n\nAlthough the published evidence is scarce and fragmentary, the cIMT retains an increasingly interesting role as a marker of atherosclerotic pathology.\n\nThe purpose of the study is to analyze cIMT in patients undergoing thyroidectomy to evaluate a possible correlation between the cIMT variation after the procedure and the cause of the thyroid disease, the levels of thyroid hormones, and the lipid or other markers of atherosclerosis levels.\n\nThe primary endpoint will be the variation of the measure of the cIMT before and after surgery.\n\nSecondary endpoints will be:\n\n* major cardiovascular adverse events (death, major stroke, minor stroke, transient ischemic attack) in the short-term period (≤30 days after the procedure);\n* major cardiovascular adverse events (death, major stroke, minor stroke, transient ischemic attack) in the long-term period (\\>30 days after the procedure);\n* the technical success of the procedure;\n* the rate of postoperative complications. To date, there are no data that differentiate patients based on the causes of thyroid disease. The results of the present study will allow for correlating the variation of the cIMT to the causes of thyroid disease, the levels of thyroid hormones, and the levels of lipid and other markers of atherosclerosis.\n\nResults from the present study may provide insights into possible areas of quality improvement. It may also influence the economic impact associated with carotid revascularization techniques, in terms of hospital charges and discharges to skilled nursing and rehabilitation facilities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the potential eligible candidates will be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing thyroidectomy according to the American Thyroid Association (ATA), International neural monitoring study group guideline (INMSG), Italian Society of Endocrine Surgery (SIUEC);\n* subjects who have read and signed the informed consent;\n* subjects who undertake to undergo the instrumental examinations and visits necessary for the study during the follow-up;\n* \\>18 years of age.\n\nExclusion Criteria:\n\n* occlusion or stenosis of at least one carotid artery, with plaque \\> 30%;\n* exposure to ionizing radiation;\n* previous neck, carotid (endarterectomy or stenting) and/or thyroid surgery;\n* clinical conditions that preclude proper follow-up;\n* HIV, dialysis therapy and all clinical conditions with increased cIMT;\n* uncontrolled dyslipidemia;\n* pregnant and breastfeeding women;\n* terminal patients.'}, 'identificationModule': {'nctId': 'NCT05774535', 'acronym': 'TIROVASC', 'briefTitle': 'Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Prospective, Observational Study on the Investigation of the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery', 'orgStudyIdInfo': {'id': '34C211'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental', 'description': 'Patients who will undergo thyroidectomy', 'interventionNames': ['Other: Experimental']}], 'interventions': [{'name': 'Experimental', 'type': 'OTHER', 'description': 'Patients will undergo thyroidectomy according to the guidelines American Thyroid Association (ATA), Randolph.\n\nThe following assessments will be performed within 10 days before the thyroidectomy procedure:\n\n* informed consent;\n* personal data and medical records;\n* registration of medical therapy and post-procedural pharmacological protocol\n* surgical check;\n* supra-aortic trunks EchocolorDoppler;\n* pre-procedural blood sampling.\n\nThe following assessments will be performed after 30 days, 6 months and 12 months from the thyroidectomy procedure:\n\n* surgical checks;\n* registration of drug therapy;\n* recording of all adverse events that occurred during hospitalization\n* supra-aortic trunks EchocolorDoppler and cIMT measurement;\n* blood sampling.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20145', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Auxologico Italiano , IRCCS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}