Hypoalbuminemia in Mild Acute Stroke and Cognitive Impariment Post-stroke

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

Study Overview

• Status: Completed
• Conditions: Stroke; Cognitive Impairment; Albumin; Double
• Intervention / Treatment: Other: strengthened nuitritional treatment

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 Type: Observational
• Enrollment (Actual): 435

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China, 523029
      • Dongguan peoples' hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hypoalbuminemia; hypoalbuminemia was classified as serum albumin level (SAL) <35g/L	Other: strengthened nuitritional treatment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSCI	Patients with a MoCA score of <24 were categorized as having PSCI	6 months post-stroke

Collaborators and Investigators

• Sponsor: Dongguan People's Hospital
• Investigators: Principal Investigator: zhu shi, dongguan peoples hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 24, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: DongguanPeopleHospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The final decision to release IPD is still pending because of the ongoing census among all paticipants's decision.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No