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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03519828
Other study ID # k(2017)34
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date January 1, 2019

Study information

Verified date July 2019
Source General Hospital of Shenyang Military Region
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 1, 2019
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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 Design


Intervention

Other:
No intervention has been conducted
It is an observational study, and no intervention has been conducted

Locations

Country Name City State
China General Hospital of ShenYang Military Region Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
Hui-Sheng Chen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 day
Primary 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. 1 day
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