Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT05040958
Status:
UNKNOWN
Last Update Posted:
2021-09-17
First Post:
2021-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Carotid Atherosclerotic Plaque Load and Neck Circumference
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-03-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-12', 'studyFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2021-09-07', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of the machine learning model and manual interpretation', 'timeFrame': '1 day', 'description': 'Evaluation of the correlation of the presence of plaque in the carotid segments with manual interpretation in the model obtained by machine learning method'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atherosclerosis of Artery', 'Metabolic Syndrome', 'Machine Learning'], 'conditions': ['Atherosclerosis of Artery', 'Metabolic Syndrome', 'Machine Learning']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to establish a deep learning model to automatically detect the presence and scoring of carotid plaques in neck CTA images, and to determine whether this model is compatible with manual interpretations.', 'detailedDescription': 'Modeling CTA images for carotid artery segments with deep learning method and automatic carotid plaque presence and scoring will be useful and beneficial in clinical practice. The aim of this study is to establish a deep learning model to automatically detect the presence and scoring of carotid plaques in neck CTA images, and to determine whether this model is compatible with manual interpretations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'People having cranial CTA', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Having cranial CTA withdrawn\n* Having blood lipids, HbA1c, blood glucose, AST, ALT measured in 3 months before and 3 months after cranial CTA\n\nExclusion Criteria:\n\n* Thyroid disease\n* Having had neck surgery\n* Use of corticosteroids for more than 6 months\n* Presence of lymph nodes in the anterior neck\n* Hypertrophy of neck muscles'}, 'identificationModule': {'nctId': 'NCT05040958', 'briefTitle': 'Carotid Atherosclerotic Plaque Load and Neck Circumference', 'organization': {'class': 'OTHER', 'fullName': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}, 'officialTitle': 'Determination of Carotid Atherosclerotic Plaque Load and Neck Circumference in Cranial CT Angiography With Machine Learning Method and Their Relationship With Each Other', 'orgStudyIdInfo': {'id': 'CAPNET'}}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Kadıköy', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Elif Yıldırım Ayaz, M.D.', 'role': 'CONTACT', 'phone': '05325148300'}], 'facility': 'Istanbul MEdeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital', 'geoPoint': {'lat': 40.97882, 'lon': 29.08268}}], 'centralContacts': [{'name': 'Elif Yıldırım Ayaz, M.D.', 'role': 'CONTACT', 'email': 'drelifyildirim@hotmail.com', 'phone': '+905325148300'}], 'overallOfficials': [{'name': 'Elif Yıldırım Ayaz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sultan Abdülhamid Han Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elif Yıldırım Ayaz', 'investigatorAffiliation': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}}}}