Magnetic Resonance AngiographyNCT04189068
Fatal Cerebral Infarction After Nasal Augmentation With Hyaluronic Acid
An observational study of Magnetic Resonance Angiography, run by Xijing Hospital at 1 site in China.
Trial summary
this study discussed the pathogenesis, treatment, and prognosis of severe cerebral infarction and ophthalmic artery occlusion for Aisan induced by hyalruonic acid filler injection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Magnetic Resonance Angiography
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2019to 22 Oct 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patient with severe cerebral infarction and ophthalmic artery occlusion after nasal augmentation by HA.
Who may be able to join
- Clinical diagnosis of cerebral infarction
Who cannot join
- fat embolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fatal Cerebral Infarction and Ophthalmic Artery Occlusion After Nasal Augmentation With Hyaluronic Acid - A Case Report and Review
this study discussed the pathogenesis, treatment, and prognosis of severe cerebral infarction and ophthalmic artery occlusion for Aisan induced by hyalruonic acid filler injection.
Read the detailed description
Intra-arterial thrombolysis and retrobulbar injection of hyaluronidase have been used for HA-induced ophthalmic artery obstruction.
- Conditions
- Magnetic Resonance Angiography
- Keywords
- Cerebral Infarction Hyaluronic Acid Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse
Monitore the "beats per minute over the past 6 days.
Measured: 0-6 day
blood pressure
Monitor the blood pressure and record with mm Hg over the past 6 days.
Measured: 0-6 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start24 Sep 2019
- Primary completion10 Oct 2019
- Study completion22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnetic Resonance AngiographyStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Qing, Xijing Hospital
- Investigators
- Ma, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189068
- Sponsor's protocol ID
- ky20192199-c-1
- Status last verified
- Dec 2019
- First submitted
- 30 Oct 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li KT, Huang YH, Chen CH, Chou LW. Delayed-onset cerebral infarction after cosmetic facial injection using hyaluronic acid. J Formos Med Assoc. 2016 Jul;115(7):587-8. doi: 10.1016/j.jfma.2015.11.012. Epub 2016 Jan 4. No abstract available.
PubMed 26763725
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatal Cerebral Infarction and Ophthalmic Artery Occlusion After Nasal Augmentation With Hyaluronic Acid - A Case Report and Review
- ClinicalTrials.gov ID
- NCT04189068
- Acronym / sponsor ID
- ky20192199-c-1
- Conditions
- Magnetic Resonance Angiography
- Keywords
- Cerebral Infarction Hyaluronic Acid Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 6 Dec 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.
this study discussed the pathogenesis, treatment, and prognosis of severe cerebral infarction and ophthalmic artery occlusion for Aisan induced by hyalruonic acid filler injection.
Detailed description
Intra-arterial thrombolysis and retrobulbar injection of hyaluronidase have been used for HA-induced ophthalmic artery obstruction.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient with severe cerebral infarction and ophthalmic artery occlusion after nasal augmentation by HA.
Key inclusion criteria (1 listed)
- Clinical diagnosis of cerebral infarction
Key exclusion criteria (1 listed)
- fat embolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pulse
Time frame: 0-6 day
Monitore the "beats per minute over the past 6 days.
blood pressure
Time frame: 0-6 day
Monitor the blood pressure and record with mm Hg over the past 6 days.
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 6 Dec 2019.
- Background: PubMed 26763725Li KT, Huang YH, Chen CH, Chou LW. Delayed-onset cerebral infarction after cosmetic facial injection using hyaluronic acid. J Formos Med Assoc. 2016 Jul;115(7):587-8. doi: 10.1016/j.jfma.2015.11.012. Epub 2016 Jan 4. No abstract available.
- Individual participant dataSharing planned: No
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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.
Ma study director
Xijing Hospital
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 Magnetic Resonance Angiography, run by Xijing Hospital at 1 site in China.
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 6 Dec 2019. 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 China. 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?
pulse (time frame: 0-6 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04189068, which also lists 1 linked publication.
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 6 Dec 2019.