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Hypoalbuminemia in Mild Acute Stroke and Cognitive Impariment Post-stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135872
Recruitment Status : Completed
First Posted : October 23, 2019
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Zhu Shi, Dongguan People's Hospital

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.

Condition or disease Intervention/treatment
Cognitive Impairment Stroke Albumin; Double 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 435 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Relationship Between Baseline Serum Albumin Level and Cognitive Impariment in Mild Acute Ischemic Stroke
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : August 30, 2018

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



Primary Outcome Measures :
  1. PSCI [ Time Frame: 6 months post-stroke ]
    Patients with a MoCA score of <24 were categorized as having PSCI


Biospecimen Retention:   Samples Without DNA
fasting venous blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135872


Locations
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China, Guangdong
Dongguan Peoples' Hospital
Dongguan, Guangdong, China, 523029
Sponsors and Collaborators
Dongguan People's Hospital
Investigators
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Principal Investigator: zhu shi dongguan peoples hospital
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Responsible Party: Zhu Shi, Deputy Director of Neurology, Dongguan People's Hospital
ClinicalTrials.gov Identifier: NCT04135872    
Other Study ID Numbers: DongguanPeopleHospital
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The final decision to release IPD is still pending because of the ongoing census among all paticipants's decision.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases