Back to resultsSafety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation
Primary Purpose
Acute Ischemic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sham remote ischemic conditioning
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- 1) Age ≥ 18 years, male or female
- 2) Diagnosis of acute ischemic stroke due to large vessel occlusion of anterior circulation (large artery occlusion confirmed by head CTA or DSA) and history of emergent endovascular thrombectomy
- 3) Baseline NIHSS ≥ 6
- 4) Premorbid mRS ≤ 2
- 5) Written informed consent obtained from the patient or legally responsible person
Exclusion Criteria:
- 1) Contraindication of endovascular thrombectomy
- 2) Contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, and subclavian steal syndrome
- 3) Head CT showing cerebral hernia and midline displacement
- 4) Pregnancy or lactation
- 5) Previous remote ischemic conditioning therapy or similar treatment
- 6) Severe hepatic and renal dysfunction
- 7) Life expectancy of less than 3 months or inability to complete the study for other reasons
- 8) Unwilling to be followed up or poor compliance
- 9) Current or past participation in other clinical research, or participation in this study within 3 months prior to admission
- 10) Other conditions that the researchers think make the patient unsuitable for the study
Sites / Locations
- The First Hospital of Jilin UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
RIC+Standard medical treatment
Sham RIC+Standard medical treatment
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 reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.
Sham 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 reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.
Outcomes
Primary Outcome Measures
Proportion of patients with modified Rankin Scale (mRS) Score 0-2
Proportion of patients with modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.
Secondary Outcome Measures
National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.
National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT. Ranged from 0 to 42, a low value represents a better outcome.
Barthel Index (BI) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.
Barthel Index (BI) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT. Ranged from 0 to 100, a high value represents a better outcome.
modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.
modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT. Ranged from 0 to 6, a low value represents a better outcome.
The expanded Thrombolysis In Cerebral Infarction (eTICI) scale immediately after EVT
eTICI grade 0 is equivalent to no reperfusion or 0% filling of the downstream territory; eTICI 1 reflects thrombus reduction without any reperfusion of distal arteries; eTICI 2a is reperfusion in less than half or 1-49% of the territory; eTICI 2b50 is 50-66% reperfusion, exceeding the modified TICI (mTICI) 2B threshold but below the original TICI 2B cut-off point; eTICI 2b67 is 67-89% reperfusion, exceeding TICI but below TICI 2C; eTICI 2c is equivalent to TICI 2C or 90-99% reperfusion; and eTICI 3 is complete or 100% reperfusion, tantamount to TICI 3.
Vascular recanalization rate 24 hours after EVT
Vascular recanalization rate 24 hours after EVT
Frequency of Hemorrhagic transformation during hospitalization
Frequency of Hemorrhagic transformation during hospitalization
Frequency of adverse events during follow-up
Severe adverse events through day-90 after the onset of acute ischemic stroke.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04977869
Brief Title
Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation
Official Title
Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation: A Multicenter, Randomized, Parallel-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (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 efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
Detailed Description
In this study, 498 cases of ischemic stroke who undergo endovascular thrombectomy within 24 hours from the onset are included in 10 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
498 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RIC+Standard medical treatment
Arm Type
Active Comparator
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 reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.
Arm Title
Sham RIC+Standard medical treatment
Arm Type
Placebo Comparator
Arm Description
Sham 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 reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.
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
Sham 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
Proportion of patients with modified Rankin Scale (mRS) Score 0-2
Description
Proportion of patients with modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.
Description
National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT. Ranged from 0 to 42, a low value represents a better outcome.
Time Frame
24 hours, 7 days, 30±3 days, 90±3 days
Title
Barthel Index (BI) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.
Description
Barthel Index (BI) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT. Ranged from 0 to 100, a high value represents a better outcome.
Time Frame
24 hours, 7 days, 30±3 days, 90±3 days
Title
modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.
Description
modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT. Ranged from 0 to 6, a low value represents a better outcome.
Time Frame
24 hours, 7 days, 30±3 days, 90±3 days
Title
The expanded Thrombolysis In Cerebral Infarction (eTICI) scale immediately after EVT
Description
eTICI grade 0 is equivalent to no reperfusion or 0% filling of the downstream territory; eTICI 1 reflects thrombus reduction without any reperfusion of distal arteries; eTICI 2a is reperfusion in less than half or 1-49% of the territory; eTICI 2b50 is 50-66% reperfusion, exceeding the modified TICI (mTICI) 2B threshold but below the original TICI 2B cut-off point; eTICI 2b67 is 67-89% reperfusion, exceeding TICI but below TICI 2C; eTICI 2c is equivalent to TICI 2C or 90-99% reperfusion; and eTICI 3 is complete or 100% reperfusion, tantamount to TICI 3.
Time Frame
immediately after EVT
Title
Vascular recanalization rate 24 hours after EVT
Description
Vascular recanalization rate 24 hours after EVT
Time Frame
24 hours,
Title
Frequency of Hemorrhagic transformation during hospitalization
Description
Frequency of Hemorrhagic transformation during hospitalization
Time Frame
7 days
Title
Frequency of adverse events during follow-up
Description
Severe adverse events through day-90 after the onset of acute ischemic stroke.
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Numeric rating scales (NRS) score during intervention
Description
Numeric rating scales (NRS) score during intervention. Ranged from 0 to 10, a low value represents a less pain.
Time Frame
7 days
Title
The number of early withdrawal for safety or tolerability reasons
Description
The number of early withdrawal for safety or tolerability reasons
Time Frame
7 days
Title
Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.
Description
Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.
Time Frame
24 hours, 7 days, 30±3 days, 90±3 days
Title
Heart rate at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.
Description
Heart rate at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.
Time Frame
24 hours, 7 days, 30±3 days, 90±3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) Age ≥ 18 years, male or female
2) Diagnosis of acute ischemic stroke due to large vessel occlusion of anterior circulation (large artery occlusion confirmed by head CTA or DSA) and history of emergent endovascular thrombectomy
3) Baseline NIHSS ≥ 6
4) Premorbid mRS ≤ 2
5) Written informed consent obtained from the patient or legally responsible person
Exclusion Criteria:
1) Contraindication of endovascular thrombectomy
2) Contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, and subclavian steal syndrome
3) Head CT showing cerebral hernia and midline displacement
4) Pregnancy or lactation
5) Previous remote ischemic conditioning therapy or similar treatment
6) Severe hepatic and renal dysfunction
7) Life expectancy of less than 3 months or inability to complete the study for other reasons
8) Unwilling to be followed up or poor compliance
9) Current or past participation in other clinical research, or participation in this study within 3 months prior to admission
10) Other conditions that the researchers think make the patient unsuitable for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Yang, MD, PhD
Phone
0086-13756661217
Email
doctor_yangyi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenni Guo, MD, PhD
Email
zhen1ni2@163.com
Facility Information:
Facility Name
The 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
Yi Yang, MD, PhD
Email
doctor_yangyi@163.com
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation
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