NCT03519828

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

April 15, 2018

Last Update Submit

July 29, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Patients with post-stroke cognitive impairment

Other: No intervention has been conducted

Patients without post-stroke cognitive impairment

Other: No intervention has been conducted

Interventions

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

Patients with post-stroke cognitive impairmentPatients without post-stroke cognitive impairment

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute ischemic stroke patients in hospital from March, 2018 to September, 2018.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of ShenYang Military Region

Shenyang, Liaoning, 10016, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2018

First Posted

May 9, 2018

Study Start

March 1, 2018

Primary Completion

December 30, 2018

Study Completion

January 1, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations