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r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery (rtPA-RIC)

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ClinicalTrials.gov Identifier: NCT02886390
Recruitment Status : Unknown
Verified June 2018 by Ji Xunming,MD,PhD, Capital Medical University.
Recruitment status was:  Recruiting
First Posted : September 1, 2016
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Xunming,MD,PhD, Capital Medical University

Study Description
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Brief Summary:
to detect the efficiency and safety of intravenous rtPA combined with RIPC in acute ischemic stroke patients

Condition or disease Intervention/treatment Phase
Stroke, Acute Device: ischemic conditioning Not Applicable

Detailed Description:
Remote ischemic post-conditioning, which consists of several brief cycles of intermittent ischemia-reperfusion of the arm or leg, may potentially confer a powerful systemic protection against prolonged ischemia in a distant organ. Numerous reports have confirmed it strongest endogenous neuroprotection against brain injury after stroke. Ren et al demonstrated that remote ischemic post-conditioning (RIPC) performed in the hind limbs can not only significantly reduce the stroke volume within 3 hours in rat model, but also ameliorate the outcome of the behavioral test. A long-term repeated RIPC therapy can also help improving neurological functions. A combination of RIPC and tPA can help with neuroprotection which improves the neurological functions. Thus, it is meaningful to transform these basic experimental results to the clinical treatment. In the RECAST-1 trial, RIC has shown it safety and efficiency in AIS patients without tPA. However, there is no further explanation for the patients with IVT. Thus, in this study, we aim to demonstrate the efficiency and safety of RIPC in AIS patients performed rt-PA within 4.5 hours.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Rt-PA Thrombolysis Combined With Remote Ischemic Post-Conditioning for Acute Ischemic Stroke Patients
Actual Study Start Date : June 16, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arms and Interventions
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Arm Intervention/treatment
Experimental: RIC group
The upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 2 hours after r-tPA thrombolytic therapy. In addition, all participants receive a standard clinical therapy.
 Device: ischemic conditioning
In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
Other Name: Doctormate, IPC-906
No Intervention: Control group
The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy.


Outcome Measures
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Primary Outcome Measures :
  1. infarction volume in brain between two groups [ Time Frame: measured during 72 h ]
    assess by MRI-DWI and ADC


Secondary Outcome Measures :
  1. The score of Modified Rankin scale score [ Time Frame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days ]
    The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). We will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment, at 90 days postoperation. The distribution of mRS will be compared between groups

  2. proportional of Modified Rankin scale scored 0-1 [ Time Frame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days ]
    The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). We will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment, at 90 days postoperation. The distribution of mRS will be compared between groups

  3. The score of National Institute of Health stroke scale score [ Time Frame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days ]
    National Institute of Health Stroke Scale (NIHSS) is considered as a standardized assessment of neurological functions in the acute phase of stroke, and it is generally used to quantify patient's neurological impairments on 15 items in 11 fields of different neurological status.The score of the scale ranges from 0 to 42.And higher score indicates worse neurological function.

  4. The score of Barthel Index(BI) [ Time Frame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days ]
    the BI is used to measure performance in activities of daily living.The score of the scale ranges from 0 to 100. And lower score indicates worse activities of daily living.

  5. recurrence of stroke and TIA [ Time Frame: changes from baseline(before RIPC) to 90±7 days ]
    Stroke recurrence was defined as sudden functional deterioration in neurologic status with a decrease of 4 or more in the NIHSS, or a new stroke lesion on MRI/DWI located at the territory of the affected intracranial arteries.

  6. death and any other adverse events [ Time Frame: changes from baseline(before RIPC) to 90±7 days ]
    The investigator will record the number.

  7. any ICH [ Time Frame: changes from baseline(before RIPC) to 90±7 days ]
    Head computed tomography or magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.

  8. Distal radial pulses [ Time Frame: during 90 days ]
    professional doctors will check the distal radial pulses

  9. Visual inspection for local edema [ Time Frame: during 90 days ]
    Professional oculists will check the fundus oculi to evaluate whether there is local edema.

  10. The number of patients with erythema,and/or skin lesions related to RIC [ Time Frame: during 90 days ]
    Professional doctors will check it and the investigator will record the number.

  11. Palpation for tenderness [ Time Frame: during 90 days ]
    Professional doctors will check it.

  12. The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure [ Time Frame: during 90 days ]
    The investigator will record the number.

  13. the score of Numeric Rating Scale (NRS) [ Time Frame: during 90 days ]
    The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. The score from 0-10. the higher

  14. the score of Hamilton Rating Scale for Depression（HAMAD） [ Time Frame: change from baseline(before rtPA) to 90 days ]
    this score was used to provide an indication of depression, and as a guide to evaluate recovery.

  15. level of MMP-9 [ Time Frame: measured at baseline(before RIPC,after rtPA) and 7 days ]
    Blood samples will be drawn from cubital vein to test these biomarkers.These samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation

  16. level of IL-6 [ Time Frame: measured at baseline(before RIPC,after rtPA) and 7 days ]
    Blood samples will be drawn from cubital vein to test these biomarkers.These samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation

  17. level of HS-CRP [ Time Frame: measured at baseline(before RIPC,after rtPA) and 7 days ]
    Blood samples will be drawn from cubital vein to test these biomarkers.These samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation

  18. The level of vascular endothelial growth factor [ Time Frame: measured at baseline(before RIPC,after rtPA) and 7 days ]
    Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation


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:

  • Male or female, age≥18;
  • Clinical sign and symptoms consistent with the diagnosis of an acute ischemic stroke, onset of stroke symptoms within 4.5 h before initiation of intravenous rt-PA thrombolytic therapy;
  • Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-15 (assessed before intravenous alteplase), mRS ≤1 before onset of stroke symptom;
  • No contraindication for MRI.
  • Informed consent obtained

Exclusion Criteria:

  • Cardioembolism；
  • Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
  • Life expectancy < 1 year;
  • Pregnant or breast-feeding women;
  • Unwilling to be followed up or poor compliance for treatment; (5) Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
Contacts and Locations
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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): NCT02886390


Contacts
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Contact: Xunming Ji, MD. PhD +86-10-83198952 jixm@ccmu.edu.cn

Locations
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China, Beijing
Xuanwu Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Ruiwen Che, MD       rwcadl@163.com   
Lu He hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 101149
Contact: Geng, MD         
Sponsors and Collaborators
Capital Medical University
Investigators
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Principal Investigator: Xunming Ji, MD. PhD Xuanwu Hospital, Beijing
More Information
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Responsible Party: Ji Xunming,MD,PhD, professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT02886390    
Other Study ID Numbers: RIC-2016
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji Xunming,MD,PhD, Capital Medical University:
remote ischemic conditioning
r-tPA thrombolytic therapy
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes