Hypoalbuminemia in Mild Acute Stroke and Cognitive Impariment Post-stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04135872
• Other study ID #: DongguanPeopleHospital
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: October 2019
• Source: Dongguan People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: August 30, 2018
• Est. primary completion date: June 30, 2018
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Albumin; Double
• Cognitive Dysfunction
• Cognitive Impairment
• Stroke

Intervention

Other:
• strengthened nuitritional treatment
improving nutritional status by nasal feeding for dysphagia or iv. albumin when serum albumin level lower than 35g/L

Locations

Country	Name	City	State
China	Dongguan Peoples' Hospital	Dongguan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Dongguan People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSCI	Patients with a MoCA score of <24 were categorized as having PSCI	6 months post-stroke