Hypoalbuminemia in Mild Acute Stroke and Cognitive Impariment Post-stroke

Completed

• Conditions: Cognitive Impairment; Stroke; Albumin; Double
• Interventions: Other: strengthened nuitritional treatment

• Registration Number: NCT04135872
• Lead Sponsor: Dongguan People's Hospital

Brief Summary

This registration enrolled patients with acute ischemic stroke within 72 hours after stroke ictus. Patients was identified as first-ever stroke based on past medical histrory. Admission CT was conducted to exclude hemorrhagic stroke, but not those bleeding transformation after ischemia injury. Baseline characteristics, including demographics, vascular risk factors, lab tests and neuroimagings were collected. Patients were followed up for cognitive assessments.

Detailed Description

This is a perspective stroke registry cohort study. Stroke patients were included if ：(1) acute first-ever ischemic stroke and admitted within 72 hours after onset; (2) clinical stroke diagnosis was confirmed with positive diffusion-weighted magnetic resonance imaging (DW-MRI), those with isolated posterior circulations infarcts were exclude ; (3) presented with mild stroke severity ( admission NIHSS score ≤5); (4) age between 40 and 80 years.

Clinical data including demographic characteristics, risk factors, and baseline NIHSS score were assessed and collected using a standardized table by experienced neurologists. Lab tests were performed with fasting venous blood samples within 18 hours of admission.

Patients were followed up for 6 months. The cognitive functions were assessed using the Chinese version of Montreal Cognitive Assessment (MoCA).

Contributing factors to post-stroke cognitive impariment (PSCI) were determined by comparing clinical data between PSCI and non-PSCI groups. All potential confounders were introduced into the multivariate regression models.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-08-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-21
• Last Update Submitted: 2019-10-22
• Study First Posted: 2019-10-23
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 435

Inclusion Criteria

1. acute first-ever ischemic stroke and admitted within 72 hours after onset;
2. clinical stroke diagnosis was confirmed with positive diffusion-weighted magnetic resonance imaging (DW-MRI), those with isolated posterior circulations infarcts were exclude ;
3. presented with mild stroke severity ( admission NIHSS score ≤5);
4. age between 40 and 80 years.

Exclusion Criteria

1. Patients with index cognitive impairment or under current anti-dementia or psychiatric medication;
2. patients with large infarcts (≥1/3 middle cerebral artery territory);
3. patients with severe language or physical disability that impede neuropsychological testing;
4. patients with recurrent transient ischemic attack (TIA)/stroke during follow-up;
5. coexisting serious conditions known to impair cognitive function

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hypoalbuminemia	strengthened nuitritional treatment	hypoalbuminemia was classified as serum albumin level (SAL) \<35g/L

Primary Outcome Measures

Name	Time	Method
PSCI	6 months post-stroke	Patients with a MoCA score of \<24 were categorized as having PSCI

Trial Locations

Locations (1)

Dongguan Peoples' Hospital; 🇨🇳 Dongguan, Guangdong, China