The Screening of Neuroprotective Biomarkers After Acute Ischemic Stroke

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Completed

CT.gov ID

NCT05689528

Collaborator

First Affiliated Hospital, Sun Yat-Sen University (Other), Nanfang Hospital of Southern Medical University (Other), Beijing Tiantan Hospital (Other)

453

Enrollment

Location

Actual Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Neuroprotection is expected to be an important therapeutic strategy for acute ischemic stroke(AIS), but almost all neuroprotective drugs proved effective in rodent models have failed after entering clinical trials. This study aims to screen the differentially expressed proteins in peripheral blood of patients with acute ischemic stroke and with further study in the animal model of non-human primate cerebral infarction, we may determine the biomarkers that can evaluate the efficacy of neuroprotective drugs.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke

Detailed Description

Acute ischemic stroke (AIS), is a major disease which cause death and disability. Globally, ischemic stroke is the second most common cause of death from vascular diseases and the third most common cause of disability. For decades, neuroprotection has been highly expected as an important treatment for cerebral ischemia, but almost all neuroprotective drugs proved effective in rodent models have failed in clinical trials. In this study, we enrolled patients with acute ischemic stroke, collecting their peripheral blood samples at 1 day and 3 months of onset. Neuropsychological scales evaluation and imaging evaluation were also completed at 1 day, 7 day and 3 months of onset respectively. Correlation research in combination with the patient's clinical information were conducted to preliminarily screen the proteins related to the prognosis of neurological function, which was reflected by patients' mRS scores at 3 months of onset, in peripheral blood. Further study in the animal model of non-human primate cerebral infarction may determine the biomarkers that can evaluate the efficacy of neuroprotective drugs.

Study Design

Study Type:

Observational

Actual Enrollment :

453 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Screening of Neuroprotective Biomarkers After Acute Ischemic Stroke

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jul 31, 2021

Outcome Measures

Primary Outcome Measures

Proteins related to the Modified Rankin Scale(mRS) score of 3 months. [3 months]
Disability by the Modified Rankin Scale(mRS) score ranging from 0-6. Higher score indicates worse function.

Secondary Outcome Measures

National Institute of Health stroke scale(NIHSS) score at 3 months. [3 months]
Disability by the National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function.
Montreal Cognitive Assessment (MoCA) [3 months]
Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.
Self-Rating Depression Scale(SDS) [3 months]
Depression assessment by Self-Rating Depression Scale(SDS) ranging from 0 to 80. Higher score indicates worse status.
Self-Rating Anxiety Scale(SAS) [3 months]
Anxiety assessment by Self-Rating Anxiety Scale(SAS) ranging from 0 to 80. Higher score indicates worse status.
Pittsburgh sleep quality index(PSQI) [3 months]
Sleep quality assessment by Pittsburgh sleep quality index(PSQI) ranging from 0-21. Higher score indicates worse sleep quality.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female, aged 50-85 years;
According to the Chinese guidelines for the diagnosis and treatment of acute ischemic stroke (2014), patients with new onset ischemic stroke with focal or regional neurological symptoms and signs, who have recovered well after the first onset or last onset (MRS score 0-1);
Onset time ≤ 48 hours;
NIHSS ≤ 25 points at visit;
Sign informed consent.

Exclusion Criteria:

The MRS score of patients with recurrent cerebral infarction was ≥ 2;
Cranial CT indicates intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.);
Patients with transient ischemic attack, cerebral arteritis, brain tumor, brain trauma, intracranial infection and brain parasitic disease;
History or evidence of any of the following diseases during the screening period: ①There was a history of surgery or trauma within 3 months before onset; ②Complicated with malignant tumor, respiratory, heart, digestive, blood or other serious or progressive diseases; ③Patients who are unable or unwilling to cooperate due to epilepsy, cognitive impairment, mental illness or physical disability (including severe aphasia).
Suspected or true history of alcohol and drug abuse;
Pregnant, lactating women or recent planned pregnancy and unwilling to use contraceptives;
The estimated survival time is less than 3 months;
The investigator believes that the patients should not participate in this clinical trial