NCT05160259

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Feb 2020Dec 2026

Study Start

First participant enrolled

February 1, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

6.9 years

First QC Date

December 3, 2021

Last Update Submit

December 3, 2021

Conditions

Keywords

Kimmerle anomaly, vertebral artery, craniovertebral insufficiency, computed tomography, transcranial Doppler

Outcome Measures

Primary Outcomes (1)

  • Radial visualization of the foramen arcuale atlantis

    acute stroke, brain tumor

    up to 36 months

Interventions

In patients with diagnosed Kimmerle's anomaly, using transcranial Doppler sonography to determine the degree of changes in blood flow in the vertebral arteries

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • acute stroke, brain tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samarkand State Medical Institute

Samarkand, 140100, Uzbekistan

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2021

First Posted

December 16, 2021

Study Start

February 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 16, 2021

Record last verified: 2021-12

Locations