Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Stroke

NCT05305625 | Unknown

• 1 other identifier: XYFY2022-KL026
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

  from baseline to 3 day

Secondary Outcomes (1)

• Differential expression pattern of differential proteins

  from baseline to 3 day

Study Arms (2)

standard therapy

EXPERIMENTAL

Patients will be treated with Guideline standard

Drug: standard therapy

remote ischemic postcondioning and standard therapy

EXPERIMENTAL

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; Drug: standard therapy

Interventions

remote ischemic postcondioning PROCEDURE

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

remote ischemic postcondioning and standard therapy

standard therapy DRUG

received standardized treatment

remote ischemic postcondioning and standard therapy; standard therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Yu Lu, MD

CONTACT

0086-18151865060; Yulumed@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: March 31, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share