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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

Tracking Information
First Submitted Date October 21, 2019
First Posted Date October 23, 2019
Last Update Posted Date October 24, 2019
Actual Study Start Date January 1, 2017
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 21, 2019)
PSCI [ Time Frame: 6 months post-stroke ]
Patients with a MoCA score of <24 were categorized as having PSCI
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Retention:   Samples Without DNA
Description:
fasting venous blood samples
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.
Condition
  • Cognitive Impairment
  • Stroke
  • Albumin; Double
Intervention Other: strengthened nuitritional treatment
improving nutritional status by nasal feeding for dysphagia or iv. albumin when serum albumin level lower than 35g/L
Study Groups/Cohorts
  • hypoalbuminemia
    hypoalbuminemia was classified as serum albumin level (SAL) <35g/L
    Intervention: Other: strengthened nuitritional treatment
  • normal albumin level
    patients with serum albumin level (SAL) of 35g/L or higher
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 21, 2019)
435
Original Actual Enrollment Same as current
Actual Study Completion Date August 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04135872
Other Study ID Numbers DongguanPeopleHospital
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Zhu Shi, Dongguan People's Hospital
Study Sponsor Dongguan People's Hospital
Collaborators Not Provided
Investigators
Principal Investigator: zhu shi dongguan peoples hospital
PRS Account Dongguan People's Hospital
Verification Date October 2019