Oxidative-reduction HomeostasisNCT03519828
Oxidation-reduction Homeostasis in Cognitive Impairment Patients After Stroke
An observational study of Oxidative-reduction Homeostasis and Post-stroke Cognitive Impairment, run by Hui-Sheng Chen at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Oxidative-reduction Homeostasis, Post-stroke Cognitive Impairment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Jan 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke patients in hospital from March, 2018 to September, 2018.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of ShenYang Military Region
Shenyang, Liaoning, 10016
About this study
Official title: 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.
- Being tested
- No intervention has been conducted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention has been conductedOther
It is an observational study, and no intervention has been conducted
| Study group | Role | What they receive |
|---|---|---|
| Patients with post-stroke cognitive impairment | Not described Receives: Other: No intervention has been conducted | |
| Patients without post-stroke cognitive impairment | Not described Receives: Other: No intervention has been conducted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative-reduction homeostasis in acute ischemic stroke patients
Reduced glutathione (GSH)/ Oxidized glutathione (GSSG), Superoxide dismutase (SOD), Catalase (CAT), Glutathione Peroxidase (GSH-PX) of acute ischemic stroke patients will be tested.
Measured: 1 day
Cognitive function in acute ischemic stroke patients
Mini Mental Status Examination (MMSE) and Montreal cognitive assessment scale (MoCA) in acute ischemic stroke patients will be evaluated.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start1 Mar 2018
- Primary completion30 Dec 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative-reduction HomeostasisStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hui-Sheng Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519828
- Sponsor's protocol ID
- k(2017)34
- Status last verified
- Jul 2019
- First submitted
- 15 Apr 2018
- Last updated
- 31 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxidation-reduction Homeostasis on Cognitive Impairment in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03519828
- Acronym / sponsor ID
- k(2017)34
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hui-Sheng ChenUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 9 May 2018 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with post-stroke cognitive impairment | – | Other: No intervention has been conducted |
| Patients without post-stroke cognitive impairment | – | Other: No intervention has been conducted |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke patients in hospital from March, 2018 to September, 2018.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| No intervention has been conductedIt is an observational study, and no intervention has been conducted | Other | Patients with post-stroke cognitive impairment, Patients without post-stroke cognitive impairment |
Primary outcome
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.
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.
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 31 Jul 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oxidative-reduction Homeostasis and Post-stroke Cognitive Impairment, run by Hui-Sheng Chen 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 5 inclusion and 6 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 31 Jul 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?
Oxidative-reduction homeostasis in acute ischemic stroke patients (time frame: 1 day). The study lists 2 primary outcomes in all. 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 31 Jul 2019.