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Remote Ischemic Conditioning and Dynamic Cerebral Autoregulation in Patients With Intracranial and Extracranial Arteriosclerosis

Primary Purpose

Carotid Stenosis, Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remote ischemic conditioning
sham remote ischemic conditioning
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Stenosis

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age≥18 years, < 80 years, regardless of sex; Patients with clinically definite diagnosis of intracranial and extracranial atherosclerosis. Baseline Glasgow Coma Scale (GCS) ≥8; Be able to accept remote ischemic conditioning; Bilateral temporal windows were well penetrated; Signed and dated informed consent is obtained Exclusion Criteria: Patients who undergo intravenous thrombolysis or endovascular treatment; Patients with consciousness disorder or restlessness who cannot cooperate with dynamic cerebral autoregulation; Patients whose stable cerebral blood flow velocity envelope cannot be obtained by transcranial Doppler ultrasound or whose cerebral blood vessels have not been detected; Patients with severe arrhythmia (frequent ventricular or supraventricular arrhythmia diagnosed by 24 hours dynamic ECG), hyperthyroidism, severe anemia, unstable blood pressure and other factors affecting the hemodynamics; CT shows cerebral hemorrhagic diseases: hemorrhagic stroke, epidural hematoma, subdural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc; Other intracranial lesions, such as cerebrovascular malformations, cerebral venous lesions, tumors and other diseases involving the brain craniocerebral planning for surgical treatment; Other serious diseases and have a life expectancy of less than 3 months; Serious blood system diseases or severe coagulation dysfunction; Severe organ dysfunction or failure; Previously received remote ischemic conditioning or similar treatment; Contraindications of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury, peripheral vascular disease in the contralateral upper limb; Unqualified laboratory test indicators: Aspartate aminotransferase or alanine aminotransferase was 3 times higher than the upper limit of normal range, serum creatinine was > 265umol/l (> 3mg/dl), platelet was < 100×109/ l, international normalized ratio (INR), activated partial thromboplastin time (APTT), prothrombin time (PT) were above the upper limit of normal range; Pregnant or lactating women; Participating in other clinical investigators, or having participated in other clinical investigators within 3 months before enrollment; Patients who do not follow up or have poor treatment compliance; Other conditions deemed inappropriate for inclusion by the investigator

Sites / Locations

  • First Hospital of Jilin UniversityRecruiting
  • First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RIC group

control group

Arm Description

RIC+Standard medical treatment. Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg.

Sham RIC+Standard medical treatment. Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg.

Outcomes

Primary Outcome Measures

Dynamic cerebral autoregulation parameters (PD)
Dynamic brain autoregulation parameters obtained from transfer function analysis in degrees. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.

Secondary Outcome Measures

Dynamic cerebral autoregulation parameters (PD)
Dynamic brain autoregulation parameters obtained from transfer function analysis in degrees. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.
Dynamic cerebral autoregulation parameters (PD)
Dynamic brain autoregulation parameters obtained from transfer function analysis in degrees. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.

Full Information

First Posted
October 10, 2022
Last Updated
February 12, 2023
Sponsor
The First Hospital of Jilin University
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1. Study Identification

Unique Protocol Identification Number
NCT05599009
Brief Title
Remote Ischemic Conditioning and Dynamic Cerebral Autoregulation in Patients With Intracranial and Extracranial Arteriosclerosis
Official Title
Remote Ischemic Conditioning and Dynamic Cerebral Autoregulation in Patients With Intracranial and Extracranial Arteriosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Jilin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to explore the effect of remote ischemic conditioning on the dynamic cerebral autoregulation in patients with intracranial and extracranial arteriosclerosis and the changes of dynamic cerebral autoregulation within 24 hours after remote ischemic conditioning.
Detailed Description
In this study, patients with intracranial and extracranial arteriosclerosis were included. The experimental group received basic treatment and remote ischemic conditioning for 200mmHg to pressurize the upper arm of the healthy side for 5 minutes, relax for 5 minutes, and repeat 4 cycles. The control group received basic treatment and remote ischemic conditioning for 60mmHg to pressurize the upper arm of the healthy side for 5 minutes, relax for 5 minutes, and repeat 4 cycles. The dynamic cerebral autoregulation was measured before treatment, immediately after treatment, 6 hours after treatment and 24 hours after treatment in both groups. The investigators aimed to determine the effect of remote ischemic conditioning on the dynamic cerebral autoregulation in patients with intracranial and extracranial arteriosclerosis. The investigators hypothesized that remote ischemic conditioning would improve dynamic cerebral autoregulation in patients with intracranial and extracranial arteriosclerosis.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
RIC group
Arm Type
Experimental
Arm Description
RIC+Standard medical treatment. Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg.
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
Sham RIC+Standard medical treatment. Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg.
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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. All patients underwent dynamic cerebral autoregulation before treatment, immediately after treatment, 6 hours after treatment and 24 hours after treatment.
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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. All patients underwent dynamic cerebral autoregulation before treatment, immediately after treatment, 6 hours after treatment and 24 hours after treatment.
Primary Outcome Measure Information:
Title
Dynamic cerebral autoregulation parameters (PD)
Description
Dynamic brain autoregulation parameters obtained from transfer function analysis in degrees. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.
Time Frame
0-6 hours
Secondary Outcome Measure Information:
Title
Dynamic cerebral autoregulation parameters (PD)
Description
Dynamic brain autoregulation parameters obtained from transfer function analysis in degrees. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.
Time Frame
0-1 hours
Title
Dynamic cerebral autoregulation parameters (PD)
Description
Dynamic brain autoregulation parameters obtained from transfer function analysis in degrees. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.
Time Frame
0-24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≥18 years, < 80 years, regardless of sex; Patients with clinically definite diagnosis of intracranial and extracranial atherosclerosis. Baseline Glasgow Coma Scale (GCS) ≥8; Be able to accept remote ischemic conditioning; Bilateral temporal windows were well penetrated; Signed and dated informed consent is obtained Exclusion Criteria: Patients who undergo intravenous thrombolysis or endovascular treatment; Patients with consciousness disorder or restlessness who cannot cooperate with dynamic cerebral autoregulation; Patients whose stable cerebral blood flow velocity envelope cannot be obtained by transcranial Doppler ultrasound or whose cerebral blood vessels have not been detected; Patients with severe arrhythmia (frequent ventricular or supraventricular arrhythmia diagnosed by 24 hours dynamic ECG), hyperthyroidism, severe anemia, unstable blood pressure and other factors affecting the hemodynamics; CT shows cerebral hemorrhagic diseases: hemorrhagic stroke, epidural hematoma, subdural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc; Other intracranial lesions, such as cerebrovascular malformations, cerebral venous lesions, tumors and other diseases involving the brain craniocerebral planning for surgical treatment; Other serious diseases and have a life expectancy of less than 3 months; Serious blood system diseases or severe coagulation dysfunction; Severe organ dysfunction or failure; Previously received remote ischemic conditioning or similar treatment; Contraindications of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury, peripheral vascular disease in the contralateral upper limb; Unqualified laboratory test indicators: Aspartate aminotransferase or alanine aminotransferase was 3 times higher than the upper limit of normal range, serum creatinine was > 265umol/l (> 3mg/dl), platelet was < 100×109/ l, international normalized ratio (INR), activated partial thromboplastin time (APTT), prothrombin time (PT) were above the upper limit of normal range; Pregnant or lactating women; Participating in other clinical investigators, or having participated in other clinical investigators within 3 months before enrollment; Patients who do not follow up or have poor treatment compliance; Other conditions deemed inappropriate for inclusion by the investigator
Facility Information:
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenni Guo
Phone
043188782080
Email
zhen1ni2@163.com
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Yang, MD, PhD
Email
doctoryangyi@163.com

12. IPD Sharing Statement

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Remote Ischemic Conditioning and Dynamic Cerebral Autoregulation in Patients With Intracranial and Extracranial Arteriosclerosis

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