NCT05689528

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
453

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
Last Updated

January 19, 2023

Status Verified

July 1, 2017

Enrollment Period

4 years

First QC Date

December 19, 2021

Last Update Submit

January 17, 2023

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic strokeneuroprotective biomarkers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • National Institute of Health stroke scale(NIHSS) score at 3 months.

    3 months

  • Montreal Cognitive Assessment (MoCA)

    3 months

  • Self-Rating Depression Scale(SDS)

    3 months

  • Self-Rating Anxiety Scale(SAS)

    3 months

  • Pittsburgh sleep quality index(PSQI)

    3 months

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute ischemic stroke

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

patients' peripheral blood

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2021

First Posted

January 19, 2023

Study Start

July 1, 2017

Primary Completion

June 30, 2021

Study Completion

July 31, 2021

Last Updated

January 19, 2023

Record last verified: 2017-07

Locations

CN(1)