Patients With Kimmerle's AnomalyNCT05160259
Radial Visualization of the Foramen Arcuale Atlantis
An observational study of Patients With Kimmerle's Anomaly, run by Samarkand State Medical Institute at 1 site in Uzbekistan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients With Kimmerle's Anomaly
- What is being tested?
- Radial visualization of the foramen arcuale atlantis
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUzbekistan
- Study dates
- 1 Feb 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- acute stroke, brain tumor
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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
- Conditions
- Patients With Kimmerle's Anomaly
- Being tested
- Radial visualization of the foramen arcuale atlantis
- Keywords
- Kimmerle anomaly, vertebral artery, craniovertebral insufficiency, computed tomography, transcranial Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial visualization of the foramen arcuale atlantisRadiation
In patients with diagnosed Kimmerle's anomaly, using transcranial Doppler sonography to determine the degree of changes in blood flow in the vertebral arteries
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial visualization of the foramen arcuale atlantis
acute stroke, brain tumor
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Feb 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Kimmerle's AnomalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samarkand State Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160259
- Sponsor's protocol ID
- Project#5
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Visualization of the Foramen Arcuale Atlantis
- ClinicalTrials.gov ID
- NCT05160259
- Acronym / sponsor ID
- Project#5
- Conditions
- Patients With Kimmerle's Anomaly
- Keywords
- Kimmerle anomaly, vertebral artery, craniovertebral insufficiency, computed tomography, transcranial Doppler
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samarkand State Medical InstituteUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- acute stroke, brain tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial visualization of the foramen arcuale atlantisIn patients with diagnosed Kimmerle's anomaly, using transcranial Doppler sonography to determine the degree of changes in blood flow in the vertebral arteries | Radiation | – |
Primary outcome
Radial visualization of the foramen arcuale atlantis
Time frame: up to 36 months
acute stroke, brain tumor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Kimmerle's Anomaly, run by Samarkand State Medical Institute at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial visualization of the foramen arcuale atlantis (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.