Posterior Reversible Encephalopathy Syndrome Clinical Trial
— POPRESOfficial title:
Prognostic Observation of Posterior Reversible Encephalopathy Syndrome
NCT number | NCT02665598 |
Other study ID # | BoGao |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | January 2024 |
Posterior Reversible Encephalopathy Syndrome (PRES) is a clinical-radiological entity, which is associated with a variety of clinical conditions. The imaging and clinical findings are typically reversible, but many patients still have permanent neurological sequelae with a fatal outcome. Up to now there are no consistent conclusions about the factors that affecting its prognosis. The objective of our study is to discuss the effects of different causes, different imaging findings and laboratory parameters on the prognosis of PRES and deepen the understanding of the nature of PRES. This will contribute to predict the prognosis of patients with PRES and to further investigate the pathogenesis of PRES so as to guide the clinical treatment and follow-up evaluation. A multi-center retrospective case study will be performed from January 2016 to July 2017 and a total of 400 patients who meet the criteria for PRES diagnosis from 10 sub-centers are anticipated included in this research. Patients will be divided into several subgroups according to the etiology. Date will be collected from the clinical records,imaging and laboratory data of the patients, including demographic data, clinical data, imaging findings, laboratory parameters and follow-up data. During the follow-up, MRI and blood biochemical examination will be performed once more. The imaging findings of the patients will be assessed by two neuroimaging physicians, any difference between them will be agreed upon by consensus. Prognosis of the patients will be assessed by using the modified Rankin scale (mRS) scores. All of the above data is saved into the database. In this study we will review etiologies and imaging findings, laboratory and follow-up data of the patients we selected. Univariate and multivariate analysis will be performed within the group and between groups according to the subgroups. Then we will discuss the connection between different causes, different imaging findings and laboratory parameters and the prognosis of posterior reversible encephalopathy syndrome.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | January 2024 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Patients who meet the criteria for PRES diagnosis:(1)typical symptoms and signs consistent with PRES, such as headache, seizures, mental status changes, visual disturbances or focal neurological deficits;(2)patients with typical or atypical imaging manifestations of PRES;(3)patients who have known risk factors of PRES. 2. Patients with definite prognosis will be included. 3. Patients with complete inpatient medical records will be included. Exclusion Criteria: 1. Patients with edema secondary to ischemia, hemorrhage, infection, inflammation, or space occupying lesions will be excluded. 2. Patients with absent or non-diagnostic MRI will be excluded. |
Country | Name | City | State |
---|---|---|---|
China | Weihai Municipal Hospital | Weihai | Shandong |
Lead Sponsor | Collaborator |
---|---|
Yantai Yuhuangding Hospital | University of Southern California |
China,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantitative assessment of short term and long term prognosis of PRES patients by mRS score | within six months |
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