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Remote Ischemic Conditioning for Chronic Cerebral Artery Occlusion

Primary Purpose

Cerebral Artery Occlusion

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Artery Occlusion

Eligibility Criteria

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

Inclusion Criteria:

  • (1) Age range 40-80 years, regardless of gender;
  • (2) Digital angiography (DSA) / ultrasound / CT angiography (CTA) / magnetic resonance angiography (MRA) showed unilateral internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion and stenosis of any other cerebral arteries (e.g. the other side of ICA or MCA, basilar artery) < 50%;
  • (3) Modified Rankin Scale (mRS) score 0-2;
  • (4) Symptoms of ischemic cerebrovascular disease (ischemic stroke or TIA) due to ICA or MCA occlusions within 12 months prior to enrollment;
  • (5) neurological deficits were stable ≥ 30 days after occlusion;
  • (6) Magnetic resonance perfusion weighted imaging (PWI) showed mean transit time (MTT) ≥ 4s and related cerebral blood flow (rCBF) (symptomatic side/asymptomatic side) < 0.95;
  • (7) The subject or its legally authorized representative is able to provide informed reports.

Exclusion Criteria:

  • (1) Uncontrolled hypertension despite the use of antihypertensive drugs before enrollment (defined as systolic blood pressure ≥200mmHg);
  • (2) Stenosis or occlusion of subclavian artery and upper limb artery;
  • (3) Previous history of cerebral hemorrhage, including intracranial hemorrhage, ischemic stroke hemorrhage transformation, vascular malformation or intracranial tumor or other parts of the active bleeding disease;
  • (4) History of brain tumor or mental illness or acute stroke ≤6 months;
  • (5) Suffering from cardiogenic thrombosis diseases, such as mitral stenosis and atrial fibrillation, myocardial infarction, mural thrombosis or valvular vegetations, congestive heart failure or endocarditis within six months;
  • (6) Obvious disorder of coagulation mechanism;
  • (7) Severe liver or kidney insufficiency, malignant tumor, or serious diseases requiring medical intervention or surgery;
  • (8) There is soft tissue or blood vessel injury at the cuff compression site of RIC treatment, or other conditions that cannot tolerate RIC;
  • (9) Pregnant or lactating women;
  • (10) Life expectancy <6 months;
  • (11) Refusal to sign informed consent, poor compliance, or inability to complete complete treatment, etc.

Sites / Locations

  • Xuanwu Hospital Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RIC group

Control group

Arm Description

Participants in the experimental group receive both RIC and standard clinical therapy. The RIC treatment is composed of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 180 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion (Patent No.CN200820123637.X, China).

Participants in the control group receive standard clinical therapy.

Outcomes

Primary Outcome Measures

Change of cerebral blood flow perfusion
The investigators evaluate the change of perfusion capacity of cerebral blood vessels on PWI-MRI.

Secondary Outcome Measures

Recurrence times of stroke or transient ischemic attack (TIA)
The investigators evaluate the times of stroke or transient ischemic attack (TIA) recurrence.
Changes of volume of WMHs
The investigators evaluate the the change of volume of WMHs on Flairs-MRI.
Change of the direction of white matter cellulose
The investigators evaluate the change of direction of white matter cellulose on DTI-MRI.
Change of cerebral hemoglobin oxygenation status
The investigators evaluate the change of cerebral hemoglobin oxygenation status on BOLD-rsfMRI.
Change of collateral circulation
The investigators evaluate the change of collateral circulation on ASL-MRI.
Change of the Montreal Cognitive Assessment (MoCA) score
The investigators evaluate the change of neurobehavioral function by the Montreal Cognitive Assessment (MoCA) score. The minimum value is 0 and maximum value is 30. The higher scores represent the better outcome.
Change of the Verbal Fluency Test (VFT) score
The investigators evaluate the change of neurobehavioral function by the Verbal Fluency Test (VFT) score. The minimum value is 0 and without the maximum value. The higher scores represent the better outcome.
Change of the Digit Span Forward and Backward score
The investigators evaluate the change of neurobehavioral function by the Digit Span Forward and Backward score. The minimum value is 3 and maximum value is 12. The higher scores represent the better outcome.
Change of the Hamilton Depression-17 (HAMD-17) scale
The investigators evaluate the change of neuropsychological function by the Hamilton Depression-17 (HAMD-17) scale. The minimum value is 0 and maximum value is 54. The higher scores represent the worse outcome.
Change of the Hamilton Anxiety (HAMA) scale
The investigators evaluate the change of neuropsychological function by the Hamilton Anxiety (HAMA) scale. The minimum value is 0 and maximum value is 56. The higher scores represent the worse outcome.
Adverse events related to RIC treatment
Adverse events related to RIC treatment, such as mucocutaneous hemorrhage, changes in coagulation function and so on.

Full Information

First Posted
March 30, 2022
Last Updated
May 13, 2022
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05342714
Brief Title
Remote Ischemic Conditioning for Chronic Cerebral Artery Occlusion
Official Title
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Chronic Cerebral Artery Occlusion: A Prospective, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

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
Chronic cerebral artery occlusion (CCAO), which is characterized by the pathophysiological change of long-term cerebral hemodynamic disorder, is one of the major risk factors affect the occurrence and recurrence of ischemic stroke. However, the mechanism of CCAO injury is not clear and effective treatment is warranted. The purpose of this study is to investigate the protective effect and underlying mechanism of remote ischemic conditioning (RIC) on CCAO.
Detailed Description
CCAO is a cerebrovascular disease due to cerebral hypo-perfusion. It is often associated with repeated ischemic stroke or transient neurological symptoms, progressive cognitive decline and reduction of daily ability. Specific and effective treatment is warranted for symptomatic management of CCAO. RIC is a non-invasive strategy to protect the brain. The clinical trials have demonstrated that daily limb RIC seems to be potentially effective in patients with symptomatic intracranial arterial stenosis in cerebral blood flow and metabolism. RIC can also ameliorate cerebral small vessel disease in slowing cognition decline and reducing white matter. Therefore, it is worth to investigate the neuroprotective mechanism of RIC for CCAO.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Artery Occlusion

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
RIC group
Arm Type
Experimental
Arm Description
Participants in the experimental group receive both RIC and standard clinical therapy. The RIC treatment is composed of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 180 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion (Patent No.CN200820123637.X, China).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group receive standard clinical therapy.
Intervention Type
Device
Intervention Name(s)
Remote ischemic conditioning
Intervention Description
The LRIC treatment consisted of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 180 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion.(Patent No.CN200820123637.X, China).
Primary Outcome Measure Information:
Title
Change of cerebral blood flow perfusion
Description
The investigators evaluate the change of perfusion capacity of cerebral blood vessels on PWI-MRI.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Recurrence times of stroke or transient ischemic attack (TIA)
Description
The investigators evaluate the times of stroke or transient ischemic attack (TIA) recurrence.
Time Frame
180 days
Title
Changes of volume of WMHs
Description
The investigators evaluate the the change of volume of WMHs on Flairs-MRI.
Time Frame
180 days
Title
Change of the direction of white matter cellulose
Description
The investigators evaluate the change of direction of white matter cellulose on DTI-MRI.
Time Frame
180 days
Title
Change of cerebral hemoglobin oxygenation status
Description
The investigators evaluate the change of cerebral hemoglobin oxygenation status on BOLD-rsfMRI.
Time Frame
180 days
Title
Change of collateral circulation
Description
The investigators evaluate the change of collateral circulation on ASL-MRI.
Time Frame
180 days
Title
Change of the Montreal Cognitive Assessment (MoCA) score
Description
The investigators evaluate the change of neurobehavioral function by the Montreal Cognitive Assessment (MoCA) score. The minimum value is 0 and maximum value is 30. The higher scores represent the better outcome.
Time Frame
180 days
Title
Change of the Verbal Fluency Test (VFT) score
Description
The investigators evaluate the change of neurobehavioral function by the Verbal Fluency Test (VFT) score. The minimum value is 0 and without the maximum value. The higher scores represent the better outcome.
Time Frame
180 days
Title
Change of the Digit Span Forward and Backward score
Description
The investigators evaluate the change of neurobehavioral function by the Digit Span Forward and Backward score. The minimum value is 3 and maximum value is 12. The higher scores represent the better outcome.
Time Frame
180 days
Title
Change of the Hamilton Depression-17 (HAMD-17) scale
Description
The investigators evaluate the change of neuropsychological function by the Hamilton Depression-17 (HAMD-17) scale. The minimum value is 0 and maximum value is 54. The higher scores represent the worse outcome.
Time Frame
180 days
Title
Change of the Hamilton Anxiety (HAMA) scale
Description
The investigators evaluate the change of neuropsychological function by the Hamilton Anxiety (HAMA) scale. The minimum value is 0 and maximum value is 56. The higher scores represent the worse outcome.
Time Frame
180 days
Title
Adverse events related to RIC treatment
Description
Adverse events related to RIC treatment, such as mucocutaneous hemorrhage, changes in coagulation function and so on.
Time Frame
From baseline to 180-day treatment
Other Pre-specified Outcome Measures:
Title
Safety of RIC [Number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC]
Description
The safety of RIC by the number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC.
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) Age range 40-80 years, regardless of gender; (2) Digital angiography (DSA) / ultrasound / CT angiography (CTA) / magnetic resonance angiography (MRA) showed unilateral internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion and stenosis of any other cerebral arteries (e.g. the other side of ICA or MCA, basilar artery) < 50%; (3) Modified Rankin Scale (mRS) score 0-2; (4) Symptoms of ischemic cerebrovascular disease (ischemic stroke or TIA) due to ICA or MCA occlusions within 12 months prior to enrollment; (5) neurological deficits were stable ≥ 30 days after occlusion; (6) Magnetic resonance perfusion weighted imaging (PWI) showed mean transit time (MTT) ≥ 4s and related cerebral blood flow (rCBF) (symptomatic side/asymptomatic side) < 0.95; (7) The subject or its legally authorized representative is able to provide informed reports. Exclusion Criteria: (1) Uncontrolled hypertension despite the use of antihypertensive drugs before enrollment (defined as systolic blood pressure ≥200mmHg); (2) Stenosis or occlusion of subclavian artery and upper limb artery; (3) Previous history of cerebral hemorrhage, including intracranial hemorrhage, ischemic stroke hemorrhage transformation, vascular malformation or intracranial tumor or other parts of the active bleeding disease; (4) History of brain tumor or mental illness or acute stroke ≤6 months; (5) Suffering from cardiogenic thrombosis diseases, such as mitral stenosis and atrial fibrillation, myocardial infarction, mural thrombosis or valvular vegetations, congestive heart failure or endocarditis within six months; (6) Obvious disorder of coagulation mechanism; (7) Severe liver or kidney insufficiency, malignant tumor, or serious diseases requiring medical intervention or surgery; (8) There is soft tissue or blood vessel injury at the cuff compression site of RIC treatment, or other conditions that cannot tolerate RIC; (9) Pregnant or lactating women; (10) Life expectancy <6 months; (11) Refusal to sign informed consent, poor compliance, or inability to complete complete treatment, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xunming Ji, MD.PhD
Phone
010-83199430
Email
jixm@ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hongrui Ma, MD
Phone
17319359172
Email
beif1995@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xunming Ji, MD.PhD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongrui Ma
Phone
17319359172
Email
beif1995@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23035060
Citation
Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.
Results Reference
result
PubMed Identifier
29042490
Citation
Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.
Results Reference
result

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Remote Ischemic Conditioning for Chronic Cerebral Artery Occlusion

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