Carotid Artery, InternalNCT04134221
Internal Carotid Artery Blood Flow in Pediatric Moyamoya Patients
An observational study of Carotid Artery, Internal, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Little is known about how general anesthesia-induced decrease in cerebral blood flow in pediatric moyamoya pateints. We investigated this question in patients undergoing moyamoya surgery, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Carotid Artery, Internal
- What is being tested?
- Ultrasound assessment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Oct 2019to 17 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric Moyamoya disease patients
Who may be able to join
- pediatric patients undergoing encephaloduroarteriosynangiosis surgery for moyamoya disease
Who cannot join
- cutaneous lesion on the neck
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on Internal Carotid Artery Blood Flow Velocity in Children With Moyamoya Disease Undergoing Surgery: a Prospective Observational Study
Little is known about how general anesthesia-induced decrease in cerebral blood flow in pediatric moyamoya pateints. We investigated this question in patients undergoing moyamoya surgery, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.
- Conditions
- Carotid Artery, Internal
- Being tested
- Ultrasound assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessmentDiagnostic test
Ultrasound assessment of internal carotid artery blood flow
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal carotid artery blood flow velocity
ultrasound assessment of internal carotid artery blood flow velocity
Measured: from anesthetic induction to end of surgery, an average of 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start18 Oct 2019
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery, InternalStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134221
- Sponsor's protocol ID
- 1910-055-106
- Status last verified
- Apr 2021
- First submitted
- 18 Oct 2019
- Last updated
- 21 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Internal Carotid Artery Blood Flow Velocity in Children With Moyamoya Disease Undergoing Surgery: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04134221
- Acronym / sponsor ID
- 1910-055-106
- Conditions
- Carotid Artery, Internal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 22 Oct 2019 (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.
Little is known about how general anesthesia-induced decrease in cerebral blood flow in pediatric moyamoya pateints. We investigated this question in patients undergoing moyamoya surgery, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric Moyamoya disease patients
Key inclusion criteria (1 listed)
- pediatric patients undergoing encephaloduroarteriosynangiosis surgery for moyamoya disease
Key exclusion criteria (1 listed)
- cutaneous lesion on the neck
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 |
|---|---|---|
| Ultrasound assessmentUltrasound assessment of internal carotid artery blood flow | Diagnostic test | – |
Primary outcome
Internal carotid artery blood flow velocity
Time frame: from anesthetic induction to end of surgery, an average of 5 hours
ultrasound assessment of internal carotid artery blood flow velocity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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 Carotid Artery, Internal, run by Seoul National University Hospital at 1 site in South Korea.
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: finished, as of the sponsor's last update on 21 Apr 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Internal carotid artery blood flow velocity (time frame: from anesthetic induction to end of surgery, an average of 5 hours). 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 21 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.