The Screening of Neuroprotective Biomarkers After Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

The Screening of Neuroprotective Biomarkers After Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05689528
• Other study ID #: 2017YFC1307500004
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: July 2017
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: July 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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:

?There was a history of surgery or trauma within 3 months before onset; ?Complicated with malignant tumor, respiratory, heart, digestive, blood or other serious or progressive diseases; ?Patients 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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Beijing Tiantan Hospital, First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteins related to the Modified Rankin Scale(mRS) score of 3 months.	Disability by the Modified Rankin Scale(mRS) score ranging from 0-6. Higher score indicates worse function.	3 months
Secondary	National Institute of Health stroke scale(NIHSS) score at 3 months.	Disability by the National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function.	3 months
Secondary	Montreal Cognitive Assessment (MoCA)	Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.	3 months
Secondary	Self-Rating Depression Scale(SDS)	Depression assessment by Self-Rating Depression Scale(SDS) ranging from 0 to 80. Higher score indicates worse status.	3 months
Secondary	Self-Rating Anxiety Scale(SAS)	Anxiety assessment by Self-Rating Anxiety Scale(SAS) ranging from 0 to 80. Higher score indicates worse status.	3 months
Secondary	Pittsburgh sleep quality index(PSQI)	Sleep quality assessment by Pittsburgh sleep quality index(PSQI) ranging from 0-21. Higher score indicates worse sleep quality.	3 months