Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke
1 other identifier
interventional
2,210
1 country
1
Brief Summary
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
July 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedOctober 2, 2024
February 1, 2024
4 years
July 13, 2021
October 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (5)
National Institute of Health stroke scale (NIHSS) at 7 days, 30±3 days, 90±3 days from onset.
7days, 30±3 days, 90±3 days
modified Rankin Scale (mRS) Score at 7 days, 30±3 days, 90±3 days from onset.
7days, 30±3 days, 90±3 days
Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset.
7days, 30±3 days, 90±3 days
Proportion of patients with hemorrhagic transformation during hospitalization.
7 days
Frequency of adverse events during follow-up.
90 days
Other Outcomes (4)
Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days.
24 hours, 7 days, 30±3 days, 90±3 days
heart rate at 24 hours, 7 days, 30±3 days, 90±3 days.
24 hours, 7 days, 30±3 days, 90±3 days
Numeric rating scales (NRS) score during intervention.
7 days
- +1 more other outcomes
Study Arms (2)
RIC+Standard medical treatment
ACTIVE COMPARATORRemote 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. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
Sham RIC+Standard medical treatment
PLACEBO COMPARATORRemote 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. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- \) Age≥18 years, regardless of sex.
- \) Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 72 hours of stroke onset.
- \) Baseline NIHSS ≥ 4, ≤ 24.
- \) Baseline mRS ≤ 2;
- \) Signed and dated informed consent is obtained.
You may not qualify if:
- \) Patients who undergo thrombolytic therapy or endovascular treatment.
- \) The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture, or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
- \) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumors,s and other diseases involving the brain.
- \) Pregnant or lactating women.
- \) Previous remote ischemic conditioning therapy or similar treatment.
- \) Severe hepatic and renal dysfunction.
- \) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
- \) Unwilling to be followed up or treated for poor compliance.
- \) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission.
- \) Other conditions that the researchers think are not suitable for the group.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yi Yanglead
Study Sites (1)
The First Hospital of Jilin University
Changchun, Jilin, 130000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associated Dean of First Hospital of Jilin University
Study Record Dates
First Submitted
July 13, 2021
First Posted
July 28, 2021
Study Start
July 1, 2021
Primary Completion
July 1, 2025
Study Completion
October 1, 2025
Last Updated
October 2, 2024
Record last verified: 2024-02