Clinical trial NCT04135872: Hypoalbuminemia in Mild Acute Stroke and Cognitive Impariment Post-stroke
Official title: Relationship Between Baseline Serum Albumin Level and Cognitive Impariment in Mild Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Stroke
Albumin; Double
Lead sponsor: Dongguan People's Hospital
Sponsor class: OTHER_GOV
First posted: 2019-10-23
Enrollment: 435
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: PSCI
timeFrame: 6 months post-stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan Peoples' Hospital
state: Guangdong
Study officials:
affiliation: dongguan peoples hospital
name: zhu shi
role: PRINCIPAL_INVESTIGATOR
References: