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

Primary Purpose

Acute Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sham remote ischemic conditioning
Sponsored by
Yi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years, <80 years, both sex; Patients with a clinically definite diagnosis of acute ischemic stroke who are able to commence RIC treatment within 72 hours of stroke onset; Baseline National Institute of Health Stroke Scale (NIHSS) score<25; Pre-onset modified Rankin Scale (mRS) score ≤ 1; Glasgow Coma Scale score ≥8; Signed and dated informed consent is obtained. Exclusion Criteria: Patients who have undergone thrombolytic therapy or endovascular therapy; 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; Presence of other intracranial lesions, such as cerebrovascular malformations, cerebral venous thrombosis, tumors, and other brain lesions; severe hepatic and renal dysfunction or failure; Patients with hematological disease, abnormal coagulation function, bleeding tendency, and platelet <100×10^9/L; 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; pregnant or lactating women; Previous RIC treatment or similar treatment; Patients with a life expectancy of less than 3 months or patients who are unable to complete the study for other reasons; unwillingness to be followed up or poor treatment adherence; 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; Other conditions that the investigator considers inappropriate for enrollment.

Sites / Locations

  • First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

RIC

Sham RIC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cerebral autoregulation at 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.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
June 20, 2023
Sponsor
Yi Yang
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1. Study Identification

Unique Protocol Identification Number
NCT05915832
Brief Title
Effects of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients With Ischemic Stroke
Acronym
RICCH-IS
Official Title
Effects of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients With Ischemic Stroke(RICCH-IS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIC
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham RIC
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic conditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham remote ischemic conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cerebral autoregulation at 7 days
Description
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.
Time Frame
0 - 7 days

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: Age ≥18 years, <80 years, both sex; Patients with a clinically definite diagnosis of acute ischemic stroke who are able to commence RIC treatment within 72 hours of stroke onset; Baseline National Institute of Health Stroke Scale (NIHSS) score<25; Pre-onset modified Rankin Scale (mRS) score ≤ 1; Glasgow Coma Scale score ≥8; Signed and dated informed consent is obtained. Exclusion Criteria: Patients who have undergone thrombolytic therapy or endovascular therapy; 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; Presence of other intracranial lesions, such as cerebrovascular malformations, cerebral venous thrombosis, tumors, and other brain lesions; severe hepatic and renal dysfunction or failure; Patients with hematological disease, abnormal coagulation function, bleeding tendency, and platelet <100×10^9/L; 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; pregnant or lactating women; Previous RIC treatment or similar treatment; Patients with a life expectancy of less than 3 months or patients who are unable to complete the study for other reasons; unwillingness to be followed up or poor treatment adherence; 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; Other conditions that the investigator considers inappropriate for enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Yang, MD,PhD
Phone
13756661217
Ext
0086
Email
doctor_yangyi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenni Guo, MD,PhD
Phone
18186872986
Ext
0086
Email
zhen1ni2@163.com
Facility Information:
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Yang, MD, PhD
Phone
18186870008
Ext
0086
Email
doctoryangyi@163.com
First Name & Middle Initial & Last Name & Degree
Zhenni Guo, MD,PhD
Phone
18186872986
Ext
0086
Email
zhen1ni2@163.com

12. IPD Sharing Statement

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Effects of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients With Ischemic Stroke

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