- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03519828
Oxidation-reduction Homeostasis in Cognitive Impairment Patients After Stroke
July 29, 2019 updated by: Hui-Sheng Chen
Effects of Oxidation-reduction Homeostasis on Cognitive Impairment in Patients With Ischemic Stroke
Cognitive impairment after ischemic stroke can affect not only the social adaptation ability, but also affect the comprehensive rehabilitation of patients.
The damage of cognitive impairment after ischemic stroke is not lower than the body function defect after stroke.
Many studies have shown that oxidative stress is one of the pathophysiological mechanisms of ischemic cerebrovascular disease.
Many studies have reported that the oxidative-reduction of cells plays an important role in the life activities of organisms, affecting the health, aging and death of the organism.
In the recent years, some scholars have suggested that post-stroke cognitive impairment may be related to oxidative-reduction homeostasis of the body, but the relevant evidence is lacking and needs to be further explored.
Therefore, the purpose of this study is to explore the effect of oxidation-reduction homeostasis on cognitive impairment in patients with ischemic stroke, and provide a theoretical basis for the prevention and treatment of cognitive impairment after ischemic stroke.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 10016
- General Hospital of Shenyang Military Region
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Acute ischemic stroke patients in hospital from March, 2018 to September, 2018.
Description
Inclusion Criteria:
- 40-80 years old;
- Ischemic stroke for the first time or previous stroke but with no serious sequelae (mRS is 0 -2 points);
- Time from onset to treatment ≤48 hours;
- Conscious awareness, and with no obvious aphasia and visual impairment;
- Signed informed consent by patient self or legally authorized representatives.
Exclusion Criteria:
- Intracranial hemorrhage or suspected subarachnoid hemorrhage;
- Transient ischemic attack;
- Patients with severe mental disorders or language disorders;
- Patients can not cooperate with evaluators, such as mental illness or dementia;
- Pregnant women or suckers;
- Researchers consider patients inappropriate to participate in the registry.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with post-stroke cognitive impairment
|
It is an observational study, and no intervention has been conducted
|
|
Patients without post-stroke cognitive impairment
|
It is an observational study, and no intervention has been conducted
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxidative-reduction homeostasis in acute ischemic stroke patients
Time Frame: 1 day
|
Reduced glutathione (GSH)/ Oxidized glutathione (GSSG), Superoxide dismutase (SOD), Catalase (CAT), Glutathione Peroxidase (GSH-PX) of acute ischemic stroke patients will be tested.
|
1 day
|
|
Cognitive function in acute ischemic stroke patients
Time Frame: 1 day
|
Mini Mental Status Examination (MMSE) and Montreal cognitive assessment scale (MoCA) in acute ischemic stroke patients will be evaluated.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2018
Primary Completion (Actual)
December 30, 2018
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
April 15, 2018
First Submitted That Met QC Criteria
April 26, 2018
First Posted (Actual)
May 9, 2018
Study Record Updates
Last Update Posted (Actual)
July 31, 2019
Last Update Submitted That Met QC Criteria
July 29, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- k(2017)34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.