Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-01 @ 8:00 AM
Study NCT ID:
NCT05160259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-12-16
First Post:
2021-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radial Visualization of the Foramen Arcuale Atlantis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-03', 'studyFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2021-12-03', 'lastUpdatePostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radial visualization of the foramen arcuale atlantis', 'timeFrame': 'up to 36 months', 'description': 'acute stroke, brain tumor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kimmerle anomaly, vertebral artery, craniovertebral insufficiency, computed tomography, transcranial Doppler'], 'conditions': ["Patients With Kimmerle's Anomaly"]}, 'descriptionModule': {'briefSummary': "Hemodynamics in the craniovertebral zone is often disturbed under the influence of a spondylogenic factor A complication of such changes can be from a slight decrease in cerebral circulation to ischemic changes in the vascular bed The patients underwent complex radiation diagnostics of the craniovertebral region of patients with verified Kimmerle's anomaly (N = 62) All examined patients underwent multispiral computed tomography (CT), ultrasound Doppler and transcranial Doppler (TCD) of the vertebral arteries (VA) Studies of the developmental variant of the first cervical vertebra with the presence of a bony bridge have shown that Kimmerle's anomaly can occur in all age groups", 'detailedDescription': "The vaulted hole was found in all age groups (more in young and middle age) The detection rate was within 16 3% of cases, that is, it occurs in every 5-6 people According to TCD data, Kimmerle's anomaly affects blood flow and was most often detected on both sides of the atlas In the unilateral variant, the anomaly was noted only on the left side It was found that the main structural change in the cerebral vascular bed, according to ultrasound diagnostics, is a change in the straightness of the vertebral arteries in the transverse processes of the cervical spine, including the atlas It should also be borne in mind that due to the complexity and mobility of the structure, patients with dysfunction of the craniovertebral zone receive therapy from doctors of various profiles, which requires a comprehensive diagnosis of this problem"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "In patients diagnosed with Kimmerle's anomaly manifested themselves in the form of dizziness, various types of headache, mainly localized in the occipital region, nausea or flashing of flies before the eyes, in the rest - only cervicalgia", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients manifested themselves in the form of dizziness, various types of headache, mainly localized in the occipital region, nausea or flashing of flies before the eyes, in the rest - only cervicalgia\n\nExclusion Criteria:\n\n* acute stroke, brain tumor'}, 'identificationModule': {'nctId': 'NCT05160259', 'briefTitle': 'Radial Visualization of the Foramen Arcuale Atlantis', 'organization': {'class': 'OTHER', 'fullName': 'Samarkand State Medical Institute'}, 'officialTitle': 'Radial Visualization of the Foramen Arcuale Atlantis', 'orgStudyIdInfo': {'id': 'Project#5'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Radial visualization of the foramen arcuale atlantis', 'type': 'RADIATION', 'description': "In patients with diagnosed Kimmerle's anomaly, using transcranial Doppler sonography to determine the degree of changes in blood flow in the vertebral arteries"}]}, 'contactsLocationsModule': {'locations': [{'zip': '140100', 'city': 'Samarkand', 'country': 'Uzbekistan', 'facility': 'Samarkand State Medical Institute', 'geoPoint': {'lat': 39.65456, 'lon': 66.96445}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samarkand State Medical Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}