Effects of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients With Ischemic Stroke (RICCH-IS)

February 26, 2024 updated by: Yi Yang

Effects of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients With Ischemic Stroke(RICCH-IS)

The purpose of this study is to determine the impact of remote ischemic conditioning on cerebral hemodynamics in patients with ischemic stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Current studies have shown that remote ischemic conditioning can activate neuronal signals and humoral factors, increase cerebral perfusion and promote neurological recovery in patients with ischemic stroke.The purpose of this study was to investigate the effect of remote ischemic conditioning on cerebral hemodynamics in patients with acute ischemic stroke.

Study Type

Interventional

Enrollment (Estimated)

120

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

  • Name: Zhenni Guo, MD,PhD
  • Phone Number: 0086 18186872986
  • Email: zhen1ni2@163.com

Study Contact Backup

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • First Hospital of Jilin University
        • Contact:
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years, <80 years, both sex;
  2. Patients with a clinically definite diagnosis of acute ischemic stroke who are able to commence RIC treatment within 72 hours of stroke onset;
  3. Baseline National Institute of Health Stroke Scale (NIHSS) score<25;
  4. Pre-onset modified Rankin Scale (mRS) score ≤ 1;
  5. Glasgow Coma Scale score ≥8;
  6. Signed and dated informed consent is obtained.

Exclusion Criteria:

  1. Patients who have undergone thrombolytic therapy or endovascular therapy;
  2. Inability to cooperate sufficiently to complete the cerebral autoregulation examination (e.g., due to a condition such as agitation, drowsiness, arrhythmia, insufficient bilateral temporal bone windows, etc.) during the recording;
  3. Presence of other intracranial lesions, such as cerebrovascular malformations, cerebral venous thrombosis, tumors, and other brain lesions;
  4. severe hepatic and renal dysfunction or failure;
  5. Patients with hematological disease, abnormal coagulation function, bleeding tendency, and platelet <100×10^9/L;
  6. Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper extremities, venous thrombosis in the acute or subacute stage of upper extremities, arterial occlusive disease, subclavian artery stenosis ≥ 50%, or subclavian steal syndrome;
  7. pregnant or lactating women;
  8. Previous RIC treatment or similar treatment;
  9. Patients with a life expectancy of less than 3 months or patients who are unable to complete the study for other reasons;
  10. unwillingness to be followed up or poor treatment adherence;
  11. Individuals who are participating in other clinical studies, have participated in other clinical studies within 3 months prior to enrollment, or have participated in this research;
  12. Other conditions that the investigator considers inappropriate for enrollment.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RIC
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days.
Procedure: Remote ischemic conditioning
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.
Placebo Comparator: Sham RIC
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days.
Procedure: Sham remote ischemic conditioning
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral autoregulation at 7 days
Time Frame: 0 - 7 days
Difference in Cerebral autoregulation at 7 days after RIC/sham-RIC between two groups. Phase difference (PD) in degree can therefore serve as a useful tool in the evaluation of cerebral autoregulation. Continuous cerebral blood flow velocities (CBFV) in cm/s of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure (ABP) in mmHg will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Data on CBFV and ABP were processed using MATLAB using scripts developed by the research team. PD was then derived from transfer function analysis to assess the dynamic association between CBFV and ABP.
0 - 7 days

Collaborators and Investigators

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

Sponsor

Yi Yang

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 (Actual)

June 25, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RICCH-IS

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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