Cognitive ImpairmentNCT04135872
Hypoalbuminemia in Mild Acute Stroke and Cognitive Impariment Post-stroke
An observational study of Cognitive Impairment and Stroke, run by Dongguan People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cognitive Impairment, Stroke, Albumin; Double
- What is being tested?
- strengthened nuitritional treatment
- Type of treatment
- Injection or infusion
- How many people
- 435 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 30 Aug 2018
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- acute first-ever ischemic stroke and admitted within 72 hours after onset;
- clinical stroke diagnosis was confirmed with positive diffusion-weighted magnetic resonance imaging (DW-MRI), those with isolated posterior circulations infarcts were exclude ;
- presented with mild stroke severity ( admission NIHSS score ≤5);
- age between 40 and 80 years.
Who cannot join
- Patients with index cognitive impairment or under current anti-dementia or psychiatric medication;
- patients with large infarcts (≥1/3 middle cerebral artery territory);
- patients with severe language or physical disability that impede neuropsychological testing;
- patients with recurrent transient ischemic attack (TIA)/stroke during follow-up;
- coexisting serious conditions known to impair cognitive function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Cognitive Impairment, Stroke, Albumin; Double
- Being tested
- strengthened nuitritional treatment
- Medical subject headings
- Cognitive Dysfunction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strengthened nuitritional treatmentOther
improving nutritional status by nasal feeding for dysphagia or iv. albumin when serum albumin level lower than 35g/L
| Study group | Role | What they receive |
|---|---|---|
| hypoalbuminemia | hypoalbuminemia was classified as serum albumin level (SAL) <35g/L Receives: Other: strengthened nuitritional treatment | |
| normal albumin level | patients with serum albumin level (SAL) of 35g/L or higher |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSCI
Patients with a MoCA score of <24 were categorized as having PSCI
Measured: 6 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start1 Jan 2017
- Primary completion30 Jun 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 435 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Dongguan People's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhu Shi, Dongguan People's Hospital
- Investigators
- zhu shi, Principal investigator, dongguan peoples hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135872
- Sponsor's protocol ID
- DongguanPeopleHospital
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The final decision to release IPD is still pending because of the ongoing census among all paticipants's decision.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Baseline Serum Albumin Level and Cognitive Impariment in Mild Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04135872
- Acronym / sponsor ID
- DongguanPeopleHospital
- Conditions
- Cognitive Impairment, Stroke, Albumin; Double
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Dongguan People's HospitalOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypoalbuminemia | – | Other: strengthened nuitritional treatmenthypoalbuminemia was classified as serum albumin level (SAL) <35g/L |
| normal albumin level | – | –patients with serum albumin level (SAL) of 35g/L or higher |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- acute first-ever ischemic stroke and admitted within 72 hours after onset;
- clinical stroke diagnosis was confirmed with positive diffusion-weighted magnetic resonance imaging (DW-MRI), those with isolated posterior circulations infarcts were exclude ;
- presented with mild stroke severity ( admission NIHSS score ≤5);
- age between 40 and 80 years.
Key exclusion criteria (5 listed)
- Patients with index cognitive impairment or under current anti-dementia or psychiatric medication;
- patients with large infarcts (≥1/3 middle cerebral artery territory);
- patients with severe language or physical disability that impede neuropsychological testing;
- patients with recurrent transient ischemic attack (TIA)/stroke during follow-up;
- coexisting serious conditions known to impair cognitive function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| strengthened nuitritional treatmentimproving nutritional status by nasal feeding for dysphagia or iv. albumin when serum albumin level lower than 35g/L | Other | hypoalbuminemia |
Primary outcome
PSCI
Time frame: 6 months post-stroke
Patients with a MoCA score of <24 were categorized as having PSCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- Individual participant dataSharing planned: Undecided. The final decision to release IPD is still pending because of the ongoing census among all paticipants's decision.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhu shi principal investigator
dongguan peoples hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Stroke, run by Dongguan People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSCI (time frame: 6 months post-stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.