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Completed

NCT Number: NCT04135872

Hypoalbuminemia in Mild Acute Stroke and Cognitive Impariment Post-stroke

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongguan Peoples' Hospital

Dongguan, Guangdong, 523029, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

strengthened nuitritional treatment

Other

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

Primary outcomes

  1. PSCI

    Time frame: 6 months post-stroke

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

Sponsors and collaborators

Lead sponsor

Dongguan People's Hospital

Other Gov

Registry information

Official study title

Relationship Between Baseline Serum Albumin Level and Cognitive Impariment in Mild Acute Ischemic Stroke

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 23, 2019
Registry last updated
Oct 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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