Kimmerle's AnomalyNCT04562259
Verification of Kimmerle's Anomaly by X-ray Methods of Research
An observational study of Kimmerle's Anomaly, run by Samarkand State Medical Institute at 1 site in Uzbekistan.
Trial summary
Kimmerle's anomaly is a bony bridge over the posterior arch of the first cervical vertebra that forms a bony ring. The vertebral artery passes through the opening. This bone bridge could theoretically be an extravasal compression of the artery and disrupt the normal blood flow to the brain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kimmerle's Anomaly
- What is being tested?
- Verification of Kimmerle's anomaly by x-ray methods of research
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUzbekistan
- Study dates
- 1 Jan 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: Patients of all ages will be examined, directed by doctors for computed tomography of the brain with the capture of the upper cervical spine and the cervical spine. with complaints of headache, dizziness, pain in the cervical region
Who may be able to join
- Patients with Kimmerle's anomaly
Who cannot join
- patients in whom the structure of the first cervical vertebra is not clearly visible
Trial locations and contacts
1 site in 1 country.
About this study
Kimmerle's anomaly is a bony bridge over the posterior arch of the first cervical vertebra that forms a bony ring. The vertebral artery passes through the opening. This bone bridge could theoretically be an extravasal compression of the artery and disrupt the normal blood flow to the brain. Evaluating the data of X-ray methods, determine the frequency of occurrence and types of Kimmerle anomaly.
Read the detailed description
It is planned to conduct an examination of 30 patients on the basis of the Department of Radiation Diagnostics and Therapy of the Samarkand State Medical Institute. Patients of all ages will be examined, directed by doctors for computed tomography of the brain with the capture of the upper cervical spine and the cervical spine. with complaints of headache, dizziness, pain in the cervical region Among those who have passed the study, it is necessary to identify patients with Kimmerle's anomaly and determine the age at which it often occurs, whether it is a congenital pathology or the result of degenerative-dystrophic changes. It is also planned to calculate the frequency of occurrence among the population, the type of this pathology (complete and incomplete bone bridge, right-sided and left-sided location), the size of the hole formed. The condition of the posterior parts of the brain will be assessed in the presence of Kimmerle's anomaly on a CT scan.
- Conditions
- Kimmerle's Anomaly
- Being tested
- Verification of Kimmerle's anomaly by x-ray methods of research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verification of Kimmerle's anomaly by x-ray methods of researchRadiation
In patients with Kimmerle's anomaly, using computed tomography of the brain with the capture of the upper cervical spine and cervical spine, it is planned to determine at what age this pathology is more common, localization of the anomaly (right, left), complete or incomplete form of the anomaly.
| Study group | Role | What they receive |
|---|---|---|
| patients with Kimmerle's anomaly | patients who have a complete or incomplete bony bridge over the posterior arch of the first cervical vertebra Receives: Radiation: Verification of Kimmerle's anomaly by x-ray methods of research |
What is being measured
The primary outcome is the main question the study is designed to answer.
In patients with Kimmerle anomaly, determine the types of forms of this pathology
In patients with Kimmerle's anomaly, using computed tomography of the brain with the capture of the upper cervical spine and cervical spine, it is planned to determine at what age this pathology is more common, localization of the anomaly (right, left), complete or incomplete form of the anomaly.
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 posted24 Sep 2020
- Study start1 Jan 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 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samarkand State Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gulshod Mardieva, docent, Study director, Samarkand State Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562259
- Sponsor's protocol ID
- Project#3
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Kimmerle's Anomaly by X-ray Methods of Research
- ClinicalTrials.gov ID
- NCT04562259
- Acronym / sponsor ID
- Project#3
- Conditions
- Kimmerle's Anomaly
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samarkand State Medical InstituteUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Sep 2020 (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.
Kimmerle's anomaly is a bony bridge over the posterior arch of the first cervical vertebra that forms a bony ring. The vertebral artery passes through the opening. This bone bridge could theoretically be an extravasal compression of the artery and disrupt the normal blood flow to the brain. Evaluating the data of X-ray methods, determine the frequency of occurrence and types of Kimmerle anomaly.
Detailed description
It is planned to conduct an examination of 30 patients on the basis of the Department of Radiation Diagnostics and Therapy of the Samarkand State Medical Institute. Patients of all ages will be examined, directed by doctors for computed tomography of the brain with the capture of the upper cervical spine and the cervical spine. with complaints of headache, dizziness, pain in the cervical region Among those who have passed the study, it is necessary to identify patients with Kimmerle's anomaly and determine the age at which it often occurs, whether it is a congenital pathology or the result of degenerative-dystrophic changes. It is also planned to calculate the frequency of occurrence among the population, the type of this pathology (complete and incomplete bone bridge, right-sided and left-sided location), the size of the hole formed. The condition of the posterior parts of the brain will be assessed in the presence of Kimmerle's anomaly on a CT scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Kimmerle's anomaly | – | Radiation: Verification of Kimmerle's anomaly by x-ray methods of researchpatients who have a complete or incomplete bony bridge over the posterior arch of the first cervical vertebra |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of all ages will be examined, directed by doctors for computed tomography of the brain with the capture of the upper cervical spine and the cervical spine. with complaints of headache, dizziness, pain in the cervical region
Key inclusion criteria (1 listed)
- Patients with Kimmerle's anomaly
Key exclusion criteria (1 listed)
- patients in whom the structure of the first cervical vertebra is not clearly visible
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 |
|---|---|---|
| Verification of Kimmerle's anomaly by x-ray methods of researchIn patients with Kimmerle's anomaly, using computed tomography of the brain with the capture of the upper cervical spine and cervical spine, it is planned to determine at what age this pathology is more common, localization of the anomaly (right, left), complete or incomplete form of the anomaly. | Radiation | patients with Kimmerle's anomaly |
Primary outcome
In patients with Kimmerle anomaly, determine the types of forms of this pathology
Time frame: up to 36 months
In patients with Kimmerle's anomaly, using computed tomography of the brain with the capture of the upper cervical spine and cervical spine, it is planned to determine at what age this pathology is more common, localization of the anomaly (right, left), complete or incomplete form of the anomaly.
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 24 Sep 2020.
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Patients With Kimmerle's Anomaly
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.
Gulshod Mardieva, docent study director
Samarkand State Medical Institute
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 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 24 Sep 2020. 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?
In patients with Kimmerle anomaly, determine the types of forms of this pathology (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 24 Sep 2020.