Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in oPRES

Cognitive Dysfunction Clinical Trial

Official title:

Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in Obstetrics Posterior Reversible Encephalopathy Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05140850
• Other study ID #: 82001568
• Status: Not yet recruiting
• Start date: January 2022
• Est. completion date: October 2023

Study information

• Verified date: November 2021
• Source: Guangzhou Medical University
• Contact: Dunjin Chen
• Phone: 18928916722
• Email: gzdrchen[@]gzhmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

1. patients were diagnosed of PE or E

2. patients received cranial image examination

3. patients consent to participate

Exclusion Criteria:

1. patients combined other neurological diseases

2. patients combined mental illness

Related Conditions & MeSH terms

• Brain Diseases
• Cognitive Dysfunction
• Neuroimaging
• Posterior Reversible Encephalopathy Syndrome
• Syndrome

Intervention

Biological:
• neuroimaging examination,neuro-cognitive test,blood pressure,blood sample
neuroimaging will be perform,neuro-cognitive will be tested,blood pressure will be monitored,blood samples will be tested

Locations

Country	Name	City	State
China	Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Dunjin Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 con?uent; 5, involved regions are fully con?uent 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.	within 10 years after deliver
Primary	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).	within 10 years after deliver
Primary	neuro-cognitive test of Montreal Cognitive Assessment	the scores of Montreal Cognitive Assessment,normal (=26); abnormal (<26).	within 10 years after deliver
Primary	blood pressure and hypertension	Hypertension: blood pressure =140/90 mmHg	within 10 years after deliver
Primary	level of lactate dehydrogenase(LDH)	inflammatory: LDH>380U/L	within 10 years after deliver
Primary	level of LDL in blood	hyperlipidemia:LDL>3.12mmol/L	within 10 years after deliver