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Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Stroke

Sponsor
The Affiliated Hospital of Xuzhou Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05305625
Collaborator
(none)
60
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Investigators aimed to investigate the changes of glymphatic function after remote ischemic postcondioning treatment in acute ischemic stroke .

Condition or Disease Intervention/Treatment Phase
  • Procedure: remote ischemic postcondioning
  • Drug: standard therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Ischemic Stroke
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: standard therapy

Patients will be treated with Guideline standard

Drug: standard therapy
received standardized treatment
Experimental: remote ischemic postcondioning and standard therapy

Patients will be treated with remote ischemic postcondioning and Guideline standard , remote ischemic postcondioning twice a day for a total of 3 days.

Procedure: remote ischemic postcondioning
remote ischemic postcondioning twice daily, for three consecutive days，the upper arm of the lighter paralyzed side was pressurized to 200mmHg, pressurized 5min and relaxed for 5 minutes for 4 cycles as a complete remote ischemic postcondioning

Drug: standard therapy
received standardized treatment

Outcome Measures

Primary Outcome Measures

  1. Changes of glial lymphatic system [from baseline to 3 day]

    The size of the vascular spaces was assessed by brain magnetic resonance of ischemic postcondioning group and standard therapy group

Secondary Outcome Measures

  1. Differential expression pattern of differential proteins [from baseline to 3 day]

    Differential expression pattern of differential proteins in blood of patients with remote ischemic postcondioning group and standard therapy group

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • The patient was 18-80 years old;

  • The NIHSS score was ≤ 25 and NIHSS > 5，Glasgow coma score ≥ 8;

  • The patients were diagnosed as anterior circulation cerebral infarction and could start remote ischemic postcondioning within 24 hours after onset

  • Normal to random time within 24 hours

  • Written informed consent signed by patients or their families

Exclusion criteria:

  • patients receiving thrombolysis or endovascular therapy;

  • modified Rankin scale (mRS) score ≥ 2 before this attack;

  • other intracranial lesions, such as cerebral hemorrhage, cerebral venous disease, severe subclavian artery stenosis and other diseases involving the brain;

  • Arterial blood pressure ≤ 90/60mmHg or ≥ 180/100mmHg after treatment.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The Affiliated Hospital of Xuzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Affiliated Hospital of Xuzhou Medical University
ClinicalTrials.gov Identifier:
NCT05305625
Other Study ID Numbers:
  • XYFY2022-KL026
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Mar 31, 2022