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CompletedNCT04135872Updated Oct 24, 2019

Hypoalbuminemia in Mild Acute Stroke and Cognitive Impariment Post-stroke

An observational study in Cognitive Impairment, Stroke and Albumin; Double, sponsored by Dongguan People's Hospital. Completed at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-24.

Sponsored by Dongguan People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
435
Ages
40 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cognitive Impairment
  • Stroke
  • Albumin; Double

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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 435 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Dongguan People's Hospital is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
435 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • hypoalbuminemia

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

    Other: strengthened nuitritional treatment

  • normal albumin level

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

Interventions

  • Otherstrengthened nuitritional treatment

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

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What researchers measure

Primary outcomes

  1. PSCI

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

    Time frame: 6 months post-stroke

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Study locations

1 site
  • Dongguan Peoples' Hospital
    Dongguan, Guangdong 523029, China
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References and documents

Individual participant data

Plan to share: Undecided — The final decision to release IPD is still pending because of the ongoing census among all paticipants's decision.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04135872
Lead sponsor
Dongguan People's Hospital
Responsible party
Zhu Shi (Deputy Director of Neurology, Dongguan People's Hospital) — Principal investigator
First posted
Oct 23, 2019
Start date
Jan 1, 2017
Primary completion
Jun 30, 2018
Completion
Aug 30, 2018
Last update
Oct 24, 2019

Study contacts

zhu shi
principal investigator · dongguan peoples hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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