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Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Ischemic Stroke (SERIC-AIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669653
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Yi Yang, First Hospital of Jilin University

Brief Summary:
he purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Procedure: Remote ischemic conditioning Procedure: Sham remote ischemic conditioning Not Applicable

Detailed Description:
In this study, 912 cases of ischemic stroke in 48 hours were included in 5 centers in China according to the principle of random, double-blind 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, 7 days in a row . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 912 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Ischemic Stroke
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : September 20, 2021
Estimated Study Completion Date : September 20, 2022

Arm Intervention/treatment
Active Comparator: 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 inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014
Procedure: 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. RIC will be conducted twice daily for 7 days.

Placebo Comparator: 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 inflations of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 days. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014
Procedure: Sham 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 60 mm Hg. RIC will be conducted twice daily for 7 days.




Primary Outcome Measures :
  1. Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 [ Time Frame: 3 months ]
    The primary outcome measure of efficacy is the modified Rankin Scale (mRS) dichotomized to define good functional outcome as mRS 0-2 at 90 days.score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.


Secondary Outcome Measures :
  1. NIHSS Score at end of 7th day of treatment [ Time Frame: 7 days ]
    NIHSS Score at end of 7th day of treatment

  2. mRS Score at end of 7th day of treatment [ Time Frame: 7 days ]
    mRS Score at end of 7th day of treatment

  3. Barthel Index at end of 7th day of treatment [ Time Frame: 7 days ]
    Barthel Index at end of 7th day of treatment

  4. Changes of hematological indicators [ Time Frame: 48h; 7days ]
    The changes of hematological indicators (inflammatory cytokine,et al.) between the first 48h and end of 7th day of treatment.



Information from the National Library of Medicine

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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 able to commence RIC treatment within 12 hours of stroke onset
  • 3)Baseline NIHSS score>5, and≤25 ;
  • 4)GCS score ≥8;
  • 5)Signed and dated informed consent is obtained

Exclusion Criteria:

  • 1) Patients with suspected posterior circulation infarction;
  • 2) Patients who undergo thrombolytic therapy or endovascular treatment;
  • 3) mRS≥2 score before the onset of the disease;
  • 4) Double upper limbs or lower limbs paralysis was found in this case;
  • 5)Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
  • 6) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
  • 7) Treated blood pressure ≤90mmHg/60mmHg or≥180mmHg/100mmHg;
  • 8) Severe organ dysfunction or failure;
  • 9) Persons suffering from severe hematological diseases or severe coagulation disorder dysfunction;
  • 10) Those who had a history of severe trauma or had major surgery within 6 months prior to admission;
  • 11) 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669653


Contacts
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Contact: Yi Yang, MD, PhD 0086-13756661217 doctor_yangyi@163.com
Contact: Zhen-Ni Guo, MD zhen1ni2@163.com

Locations
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China, Jilin
First Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130000
Contact: Yi Yang, MD, PhD       doctor_yangyi@163.com   
Sponsors and Collaborators
Yi Yang
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Responsible Party: Yi Yang, Clinical Trial and Research Center for Stroke, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT03669653    
Other Study ID Numbers: SERIC-AIS
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia