Clinical Trial: Prognostic Observation of Posterior Reversible Encephalopathy Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Prognostic Observation of Posterior Reversible Encephalopathy Syndrome
Brief Summary: 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 parame
Detailed Summary:
Background and Significance
Posterior Reversible Encephalopathy Syndrome (PRES) is a clinical-radiological syndrome. It was first described by Hinchey et al. in 1996. It is characterized by a variable combination of headaches, seizures, altered mental status, visual impairment, nausea, vomiting and focal neurological signs and accompanied with symmetric vasogenic edema of bilateral posterior cerebral circulation territory. PRES is associated with multiple risk factors, such as renal dysfunction, hypertension, cytotoxic drugs, autoimmune disease and pre-eclampsia or eclampsia, which can occur in a wide range of diseases and predisposing factors. Lesions are usually located in the parietal occipital region. However, lesions may also involve unilateral cerebral hemisphere, anterior circulation area or deep brain structure. According to the location of the lesions, five distribution patterns were described: mainly parietal-occipital pattern, superior frontal sulcus pattern, holo-hemispheric watershed pattern, partial or asymmetric expression of the primary patterns and central pattern. In addition, cytotoxic edema with associated diffusion restriction, abnormal enhancement due to blood brain barrier disruption, hemorrhages, infarction are atypical findings which may be occasionally detected.
PRES is associated with a variety of clinical conditions. The occurrence of PRES is not affected by age and gender, it may present in all age groups. The occurrence of PRES may be a result of either breakdown of cerebral autoregulation and disruption of blood brain barrier, causing vasogenic edema or endothelial dysfunction resulting from circulating toxic mediators, sepsis, autoimmune conditions, or eclampsia. Up to now, the pathophysiological mechanism of PRES is still not clear, but cerebral autoregulation impairment and endothelial dys
Sponsor: Yantai Yuhuangding Hospital
Current Primary Outcome: Quantitative assessment of short term and long term prognosis of PRES patients by mRS score [ Time Frame: within six months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Yantai Yuhuangding Hospital
Dates:
Date Received: January 3, 2016
Date Started: April 2016
Date Completion: January 2017
Last Updated: April 9, 2016
Last Verified: April 2016
