Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Stroke

March 30, 2022 updated by: The Affiliated Hospital of Xuzhou Medical University

Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Ischemic Stroke

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Drug: standard therapy
received standardized treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of glial lymphatic system
Time Frame: 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
from baseline to 3 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differential expression pattern of differential proteins
Time Frame: from baseline to 3 day
Differential expression pattern of differential proteins in blood of patients with remote ischemic postcondioning group and standard therapy group
from baseline to 3 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Xuzhou Medical University

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 (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY2022-KL026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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