Back to resultsEffect of Remote Ischemic Postcondioning on Glymphatic System in Acute Stroke
Primary Purpose
Stroke
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
remote ischemic postcondioning
standard therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
standard therapy
remote ischemic postcondioning and standard therapy
Arm Description
Patients will be treated with Guideline standard
Patients will be treated with remote ischemic postcondioning and Guideline standard , remote ischemic postcondioning twice a day for a total of 3 days.
Outcomes
Primary Outcome Measures
Changes of glial lymphatic system
The size of the vascular spaces was assessed by brain magnetic resonance of ischemic postcondioning group and standard therapy group
Secondary Outcome Measures
Differential expression pattern of differential proteins
Differential expression pattern of differential proteins in blood of patients with remote ischemic postcondioning group and standard therapy group
Full Information
NCT ID
NCT05305625
First Posted
January 25, 2022
Last Updated
March 30, 2022
Sponsor
The Affiliated Hospital of Xuzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05305625
Brief Title
Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Stroke
Official Title
Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Xuzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigators aimed to investigate the changes of glymphatic function after remote ischemic postcondioning treatment in acute ischemic stroke .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard therapy
Arm Type
Experimental
Arm Description
Patients will be treated with Guideline standard
Arm Title
remote ischemic postcondioning and standard therapy
Arm Type
Experimental
Arm Description
Patients will be treated with remote ischemic postcondioning and Guideline standard , remote ischemic postcondioning twice a day for a total of 3 days.
Intervention Type
Procedure
Intervention Name(s)
remote ischemic postcondioning
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
standard therapy
Intervention Description
received standardized treatment
Primary Outcome Measure Information:
Title
Changes of glial lymphatic system
Description
The size of the vascular spaces was assessed by brain magnetic resonance of ischemic postcondioning group and standard therapy group
Time Frame
from baseline to 3 day
Secondary Outcome Measure Information:
Title
Differential expression pattern of differential proteins
Description
Differential expression pattern of differential proteins in blood of patients with remote ischemic postcondioning group and standard therapy group
Time Frame
from baseline to 3 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Lu, MD
Phone
0086-18151865060
Email
Yulumed@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Stroke
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