Effect of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Patients With Intravenous Thrombolysis (SRICDCA-IVT)
NCT ID: NCT05550103
Last Updated: 2022-10-26
Study Results
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Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-10-01
2023-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RIC+Standard medical treatment
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 consecutive days from thrombolysis.
Remote ischemic conditioning
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 inflations of a blood pressure cuff to 200 mm Hg.
Standard medical treatment
Standard medical treatment
Sham RIC+Standard medical treatment
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 consecutive days from thrombolysis.
Sham remote ischemic conditioning
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 inflations of a blood pressure cuff to 60 mm Hg.
Standard medical treatment
Standard medical treatment
Interventions
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Remote ischemic conditioning
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 inflations of a blood pressure cuff to 200 mm Hg.
Sham remote ischemic conditioning
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 inflations of a blood pressure cuff to 60 mm Hg.
Standard medical treatment
Standard medical treatment
Eligibility Criteria
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Inclusion Criteria
* 2\) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis with alteplase in 4.5 hours;
* 3\) Baseline mRs 2-5; and Premorbid mRS ≤ 1；
* 4\) Baseline NIHSS\>= 4, and \<= 24;
* 5\) Signed and dated informed consent is obtained;
Exclusion Criteria
* 2\) Patients with consciousness disorder or restlessness who cannot cooperate with dynamic cerebral autoregulation;
* 3\) Patients whose stable cerebral blood flow velocity envelope cannot be obtained by transcranial Doppler ultrasound or whose cerevral blood vessels have not been detected;
* 4\) The patients who have 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;
* 5\) Pregnant or lactating women;
* 6\) Previous remote ischemic conditioning therapy or similar treatment;
* 7\) Laboratory indicators are not qualified: Alanine transaminase (ALT) or glutamic-oxalacetic transaminase (AST) continued to rise more than 3 times the upper limit of normal, Serum creatinine \> 265 umol/l (\> 3.0 mg/dl);
* 8\) Previous history of atrial fibrillation or ECG showing atrial fibrillation or arrhythmia;
* 9\) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
* 10\) Unwilling to be followed up or treated for poor compliance;
* 11\) 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;
* 12\) Other conditions that the researchers think are not suitable for the group.
18 Years
ALL
No
Sponsors
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Yi Yang
OTHER
Responsible Party
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Yi Yang
Associated Dean of First Hospital of Jilin University
Locations
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The First Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SRICDCA-IVT
Identifier Type: -
Identifier Source: org_study_id
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