Hypoalbuminemia in Mild Acute Stroke and Cognitive Impariment Post-stroke

NCT04135872 | Completed

• 1 other identifier: DongguanPeopleHospital
• Study Type: observational
• Target: 435
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Stroke; Albumin; Double

Outcome Measures

Primary Outcomes (1)

• PSCI

  Patients with a MoCA score of \<24 were categorized as having PSCI

  6 months post-stroke

Study Arms (2)

hypoalbuminemia

hypoalbuminemia was classified as serum albumin level (SAL) \<35g/L

Other: strengthened nuitritional treatment

normal albumin level

patients with serum albumin level (SAL) of 35g/L or higher

Interventions

strengthened nuitritional treatment OTHER

improving nutritional status by nasal feeding for dysphagia or iv. albumin when serum albumin level lower than 35g/L

hypoalbuminemia

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were continuously enrolled from a perspective stroke registry between January 1, 2017 and June 31, 2018, in Dongguan People's Hospital, Guangdong, China.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dongguan People's Hospital: lead

Study Sites (1)

Dongguan Peoples' Hospital

Dongguan, Guangdong, 523029, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

fasting venous blood samples

MeSH Terms

Conditions

Cognitive Dysfunction; Stroke

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• zhu shi

  dongguan peoples hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Neurology

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: January 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: August 30, 2018
• Last Updated: October 24, 2019

Record last verified: 2019-10

Locations

CN (1)