NeuroimagingNCT05140850
Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in oPRES
An observational study of Neuroimaging and Cognitive Dysfunction, run by Dunjin Chen at 1 site in China.
Trial summary
The purpose of this study is to explore the long-term consequences of neuroimaging and perceived cognitive dysfunction in obstetrics posterior reversible encephalopathy syndrome. Read more about this study
- Who is it for?
- Ages 15 to 60 years, women only
- Conditions the study is for
- Neuroimaging, Cognitive Dysfunction, Posterior Reversible Encephalopathy Syndrome
- What is being tested?
- neuroimaging examination,neuro-cognitive test,blood pressure,blood sample
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2022to Oct 2023
- How long will I take part?
- 2 Years
- 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 15 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: We divided the PE or E patients into two groups, namely PRES group and non-PRES group, according to diagnostic criteria . the general information（demographic data，blood pressure.etc.）and blood sample will be collected.
Who may be able to join
- patients were diagnosed of PE or E
- patients received cranial image examination
- patients consent to participate
Who cannot join
- patients combined other neurological diseases
- patients combined mental illness
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510150
About this study
Official title: Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in Obstetrics Posterior Reversible Encephalopathy Syndrome
The purpose of this study is to explore the long-term consequences of neuroimaging and perceived cognitive dysfunction in obstetrics posterior reversible encephalopathy syndrome.
Read the detailed description
This is a prospective study. The investigators divided the PE or E patients into two groups, namely PRES group and non-PRES group, according to diagnostic criteria . The general information（demographic data，blood pressure.etc.）and blood sample will be collected. Additionally,all patients receive neuroimaging examination（DTI,ASL,3D-TMI.etc.）and neuro-cognitive test（MMSE,MOCA,CFQ, etc.） to assess the cerebral white matter lesions and cognitive changes.
- Being tested
- neuroimaging examination,neuro-cognitive test,blood pressure,blood sample
- Medical subject headings
- Cognitive Dysfunction, Posterior Leukoencephalopathy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuroimaging examination,neuro-cognitive test,blood pressure,blood sampleBiological
neuroimaging will be perform,neuro-cognitive will be tested,blood pressure will be monitored,blood samples will be tested
| Study group | Role | What they receive |
|---|---|---|
| PRES group | PE or E with PRES Receives: Biological: neuroimaging examination,neuro-cognitive test,blood pressure,blood sample | |
| non-PRES group | PE or E without PRES Receives: Biological: neuroimaging examination,neuro-cognitive test,blood pressure,blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuroimaging examination
the degree of white matter lesions(0,normal; 1, limited cortical or subcortical white matter oedema; 2, white matter oedema > cortical oedema, white matter oedema extending into deep white matter; 3, white matter oedema > cortex oedema, oedema extending to the ventricular surface; 4, the involved regions substantially extend to the ventricular surface and are almost completely confluent; 5, involved regions are fully confluent and continuous, ventricular deformity due to the oedema).The value of fractional anisotropy(FA) in PRES group may higher than non- PRES group, and mean diffusivity (MD) in PRES group may lower than non- PRES group.
Measured: within 10 years after deliver
neuro-cognitive test of Mini-mental State Examination
the scores of Mini-mental State Examination,normal (27-30);mild (21-26); moderate (10-20); severe (0-9).
Measured: within 10 years after deliver
neuro-cognitive test of Montreal Cognitive Assessment
the scores of Montreal Cognitive Assessment,normal (≥26); abnormal (<26).
Measured: within 10 years after deliver
blood pressure and hypertension
Hypertension: blood pressure ≥140/90 mmHg
Measured: within 10 years after deliver
level of lactate dehydrogenase(LDH)
inflammatory: LDH>380U/L
Measured: within 10 years after deliver
level of LDL in blood
hyperlipidemia：LDL>3.12mmol/L
Measured: within 10 years after deliver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroimagingStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Dunjin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dunjin Chen, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140850
- Sponsor's protocol ID
- 82001568
- Status last verified
- Nov 2021
- First submitted
- 9 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in Obstetrics Posterior Reversible Encephalopathy Syndrome
- ClinicalTrials.gov ID
- NCT05140850
- Acronym / sponsor ID
- 82001568
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Dunjin ChenUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 1 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.
The purpose of this study is to explore the long-term consequences of neuroimaging and perceived cognitive dysfunction in obstetrics posterior reversible encephalopathy syndrome.
Detailed description
This is a prospective study. The investigators divided the PE or E patients into two groups, namely PRES group and non-PRES group, according to diagnostic criteria . The general information（demographic data，blood pressure.etc.）and blood sample will be collected. Additionally,all patients receive neuroimaging examination（DTI,ASL,3D-TMI.etc.）and neuro-cognitive test（MMSE,MOCA,CFQ, etc.） to assess the cerebral white matter lesions and cognitive changes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRES group | – | Biological: neuroimaging examination,neuro-cognitive test,blood pressure,blood samplePE or E with PRES |
| non-PRES group | – | Biological: neuroimaging examination,neuro-cognitive test,blood pressure,blood samplePE or E without PRES |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We divided the PE or E patients into two groups, namely PRES group and non-PRES group, according to diagnostic criteria . the general information（demographic data，blood pressure.etc.）and blood sample will be collected.
Key inclusion criteria (3 listed)
- patients were diagnosed of PE or E
- patients received cranial image examination
- patients consent to participate
Key exclusion criteria (2 listed)
- patients combined other neurological diseases
- patients combined mental illness
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 |
|---|---|---|
| neuroimaging examination,neuro-cognitive test,blood pressure,blood sampleneuroimaging will be perform,neuro-cognitive will be tested,blood pressure will be monitored,blood samples will be tested | Biological | PRES group, non-PRES group |
Primary outcome
neuroimaging examination
Time frame: within 10 years after deliver
the degree of white matter lesions(0,normal; 1, limited cortical or subcortical white matter oedema; 2, white matter oedema > cortical oedema, white matter oedema extending into deep white matter; 3, white matter oedema > cortex oedema, oedema extending to the ventricular surface; 4, the involved regions substantially extend to the ventricular surface and are almost completely confluent; 5, involved regions are fully confluent and continuous, ventricular deformity due to the oedema).The value of fractional anisotropy(FA) in PRES group may higher than non- PRES group, and mean diffusivity (MD) in PRES group may lower than non- PRES group.
neuro-cognitive test of Mini-mental State Examination
Time frame: within 10 years after deliver
the scores of Mini-mental State Examination,normal (27-30);mild (21-26); moderate (10-20); severe (0-9).
neuro-cognitive test of Montreal Cognitive Assessment
Time frame: within 10 years after deliver
the scores of Montreal Cognitive Assessment,normal (≥26); abnormal (<26).
blood pressure and hypertension
Time frame: within 10 years after deliver
Hypertension: blood pressure ≥140/90 mmHg
level of lactate dehydrogenase(LDH)
Time frame: within 10 years after deliver
inflammatory: LDH>380U/L
level of LDL in blood
Time frame: within 10 years after deliver
hyperlipidemia：LDL>3.12mmol/L
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- 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.
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 Neuroimaging and Cognitive Dysfunction, run by Dunjin Chen 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dunjin Chen (18928916722, gzdrchen@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuroimaging examination (time frame: within 10 years after deliver). The study lists 6 primary outcomes in all. 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 8 Dec 2021.