Hypoalbuminemia in Mild Acute Stroke and Cognitive Impariment Post-stroke

NCT ID: NCT04135872

Last Updated: 2019-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 435 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-08-30

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.

Conditions

Cognitive Impairment; Stroke; Albumin; Double

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

hypoalbuminemia

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

strengthened nuitritional treatment

Intervention Type: OTHER

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

normal albumin level

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

No interventions assigned to this group

Interventions

strengthened nuitritional treatment

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongguan People's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zhu Shi

Deputy Director of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zhu shi

Role: PRINCIPAL_INVESTIGATOR

dongguan peoples hospital

Locations

Dongguan Peoples' Hospital

Dongguan, Guangdong, China

Countries

China

Other Identifiers

DongguanPeopleHospital

Identifier Type: -

Identifier Source: org_study_id