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出境医 / 临床实验 / Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke (SERICT-AIS)

Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke (SERICT-AIS)

Study Description
Brief Summary:
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Device: remote ischemic conditioning Device: sham remote ischemic conditioning Not Applicable

Detailed Description:
In this study, 50 cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : January 1, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: RIC group
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 mm Hg. RIC will be conducted twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
Device: remote ischemic conditioning
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 mm Hg.

Placebo Comparator: control group
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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014
Device: 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.

Outcome Measures
Primary Outcome Measures :
  1. Frequency of adverse events during hospitalization [ Time Frame: 7 days ]
    All adverse events until day-7 or discharge (whichever is earlier)

  2. Frequency of adverse events during follow-up [ Time Frame: 3 months ]
    Severe adverse events through day-90 after the onset of acute ischemic stroke.


Secondary Outcome Measures :
  1. National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge [ Time Frame: 7 days ]
    National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge. Ranged from 0 to 42, a low value represents a better outcome.

  2. Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 [ Time Frame: 3 months ]
    Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.


Other Outcome Measures:
  1. Changes of hematological indicators [ Time Frame: 24 hours ]
    Hematological samples are collected at right before thrombolysis and 24 hours after thrombolysis, and changes of hematological indicators related to hemorrhagic transformation (such as Axl, ANGPTL4) are compared between the two groups.

  2. Changes of the function of dynamic cerebral autoregulation [ Time Frame: 10 days ]
    The function of patients' dynamic cerebral autoregulation are tested 3 times within 10 days from onset and compared between the two groups.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) Age≥18 years, < 80 years, regardless of sex;
  • 2) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
  • 3) Baseline NIHSS >= 5, and <= 25;
  • 4) Baseline GCS ≥8;
  • 5) Signed and dated informed consent is obtained

Exclusion Criteria:

  • 1) Patients who undergo endovascular treatment;
  • 2) mRS ≥ 2 before the onset of the disease;
  • 3) Double upper limbs or lower limbs paralysis was found in this case;
  • 4) Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
  • 5) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
  • 6) Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
  • 7) Severe organ dysfunction or failure;
  • 8) Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
  • 9) Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
  • 10) Those who have a history of atrial fibrillation;
  • 11) 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;
  • 12) Pregnant or lactating women;
  • 13) Previous remote ischemic conditioning therapy or similar treatment;
  • 14) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
  • 15) Severe hepatic and renal dysfunction;
  • 16) Unwilling to be followed up or treated for poor compliance;
  • 17) 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;
  • 18) Other conditions that the researchers think are not suitable for the group.
Contacts and Locations

Locations
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China, Jilin
The First Hospital of Jilin University
Chang chun, Jilin, China, 130000
Sponsors and Collaborators
Yi Yang
Tracking Information
First Submitted Date  ICMJE July 14, 2019
First Posted Date  ICMJE July 22, 2019
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE July 1, 2019
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Frequency of adverse events during hospitalization [ Time Frame: 7 days ]
    All adverse events until day-7 or discharge (whichever is earlier)
  • Frequency of adverse events during follow-up [ Time Frame: 3 months ]
    Severe adverse events through day-90 after the onset of acute ischemic stroke.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge [ Time Frame: 7 days ]
    National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge. Ranged from 0 to 42, a low value represents a better outcome.
  • Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 [ Time Frame: 3 months ]
    Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 18, 2019)
  • Changes of hematological indicators [ Time Frame: 24 hours ]
    Hematological samples are collected at right before thrombolysis and 24 hours after thrombolysis, and changes of hematological indicators related to hemorrhagic transformation (such as Axl, ANGPTL4) are compared between the two groups.
  • Changes of the function of dynamic cerebral autoregulation [ Time Frame: 10 days ]
    The function of patients' dynamic cerebral autoregulation are tested 3 times within 10 days from onset and compared between the two groups.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke
Official Title  ICMJE Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke
Brief Summary The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.
Detailed Description In this study, 50 cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Ischemic Stroke
Intervention  ICMJE
  • Device: remote ischemic conditioning
    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 mm Hg.
  • Device: 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.
Study Arms  ICMJE
  • Active Comparator: RIC group
    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 mm Hg. RIC will be conducted twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
    Intervention: Device: remote ischemic conditioning
  • Placebo Comparator: control group
    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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014
    Intervention: Device: sham remote ischemic conditioning
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2020
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1) Age≥18 years, < 80 years, regardless of sex;
  • 2) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
  • 3) Baseline NIHSS >= 5, and <= 25;
  • 4) Baseline GCS ≥8;
  • 5) Signed and dated informed consent is obtained

Exclusion Criteria:

  • 1) Patients who undergo endovascular treatment;
  • 2) mRS ≥ 2 before the onset of the disease;
  • 3) Double upper limbs or lower limbs paralysis was found in this case;
  • 4) Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
  • 5) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
  • 6) Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
  • 7) Severe organ dysfunction or failure;
  • 8) Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
  • 9) Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
  • 10) Those who have a history of atrial fibrillation;
  • 11) 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;
  • 12) Pregnant or lactating women;
  • 13) Previous remote ischemic conditioning therapy or similar treatment;
  • 14) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
  • 15) Severe hepatic and renal dysfunction;
  • 16) Unwilling to be followed up or treated for poor compliance;
  • 17) 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;
  • 18) Other conditions that the researchers think are not suitable for the group.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04027621
Other Study ID Numbers  ICMJE SERICT-AIS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yi Yang, The First Hospital of Jilin University
Study Sponsor  ICMJE Yi Yang
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Hospital of Jilin University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP