- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05689528
The Screening of Neuroprotective Biomarkers After Acute Ischemic Stroke
January 17, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
453
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with acute ischemic stroke
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proteins related to the Modified Rankin Scale(mRS) score of 3 months.
Time Frame: 3 months
|
Disability by the Modified Rankin Scale(mRS) score ranging from 0-6.
Higher score indicates worse function.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
National Institute of Health stroke scale(NIHSS) score at 3 months.
Time Frame: 3 months
|
Disability by the National Institute of Health stroke scale(NIHSS) score ranging from 0-42.
Higher score indicates worse function.
|
3 months
|
Montreal Cognitive Assessment (MoCA)
Time Frame: 3 months
|
Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30.
Lower score indicates worse cognitive function.
|
3 months
|
Self-Rating Depression Scale(SDS)
Time Frame: 3 months
|
Depression assessment by Self-Rating Depression Scale(SDS) ranging from 0 to 80. Higher score indicates worse status.
|
3 months
|
Self-Rating Anxiety Scale(SAS)
Time Frame: 3 months
|
Anxiety assessment by Self-Rating Anxiety Scale(SAS) ranging from 0 to 80. Higher score indicates worse status.
|
3 months
|
Pittsburgh sleep quality index(PSQI)
Time Frame: 3 months
|
Sleep quality assessment by Pittsburgh sleep quality index(PSQI) ranging from 0-21.
Higher score indicates worse sleep quality.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
July 31, 2021
Study Registration Dates
First Submitted
December 19, 2021
First Submitted That Met QC Criteria
January 17, 2023
First Posted (Actual)
January 19, 2023
Study Record Updates
Last Update Posted (Actual)
January 19, 2023
Last Update Submitted That Met QC Criteria
January 17, 2023
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017YFC1307500004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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