The Screening of Neuroprotective Biomarkers After Acute Ischemic Stroke

Completed

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT05689528
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

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 Timeline

• Status Verified: 2017-07
• Study Start: 2017-07-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-31
• Study First Submitted: 2021-12-19
• Study First Submitted QC: 2023-01-17
• Last Update Submitted: 2023-01-17
• Study First Posted: 2023-01-19
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 453

Inclusion Criteria

1. Male or female, aged 50-85 years;
2. 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);
3. Onset time ≤ 48 hours;
4. NIHSS ≤ 25 points at visit;
5. Sign informed consent.

Exclusion Criteria

1. The MRS score of patients with recurrent cerebral infarction was ≥ 2;
2. Cranial CT indicates intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.);
3. Patients with transient ischemic attack, cerebral arteritis, brain tumor, brain trauma, intracranial infection and brain parasitic disease;
4. 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).
5. Suspected or true history of alcohol and drug abuse;
6. Pregnant, lactating women or recent planned pregnancy and unwilling to use contraceptives;
7. The estimated survival time is less than 3 months;
8. The investigator believes that the patients should not participate in this clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	3 months	Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.
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.
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.
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.
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.

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China