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Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke (REVISE-2)

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ClinicalTrials.gov Identifier: NCT03045055
Recruitment Status : Unknown
Verified March 2018 by Ji Xunming, Xuanwu Hospital, Beijing.
Recruitment status was:  Not yet recruiting
First Posted : February 7, 2017
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Xunming, Xuanwu Hospital, Beijing

Brief Summary:

Ischemic stroke, which is due to the occlusion of a cerebral blood vessel, comprises nearly 90% of all strokes. Currently, reperfusion of the salvageable tissue via thrombolytic drug or endovascular treatment is the most effective strategy to reduce brain damage. However, after recanalizing the occluded vessels, subsequent reperfusion injury is inevitable. It may not only weaken the therapeutic effects of timely reperfusion but also impede patients' recovery. Moreover, thousands of neuroprotective drugs effective in experimental models have been proved to be unsuccessful in clinical trials. Therefore, effective strategies are urgently needed to prevent and treat cerebral reperfusion injury and further improve the prognosis of acute ischemic stroke.

Researchers applied remote ischemic conditioning to mouse model of focal cerebral reperfusion injury and found that it could reduce cerebral infarct size. And clinical researches demonstrated that remote ischemic conditioning was an effective strategy to improve cerebral perfusion and prevent recurrent stroke in patients with ischemic stroke. However, whether remote ischemic conditioning is safe and effective in protecting patients with large-vessel ischemic stroke and undergoing endovascular treatment is still unclear. The investigators' hypothesis is that RIC is a safe and effective strategy to reduce brain injuries in stroke patients undergoing endovascular treatment.


Condition or disease Intervention/treatment Phase
Acute Stroke Device: Remote ischemic conditioning. Procedure: Endovascular treatment. Device: Sham remote ischemic conditioning Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Proof-of-Concept Study Assessing the Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke Patients Undergoing Endovascular Treatment
Estimated Study Start Date : March 20, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: RIC group
RIC (remote ischemic conditioning) paired with endovascular treatment.
Device: Remote ischemic conditioning.
RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on unilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeately for 4 times.
Other Name: RIC

Procedure: Endovascular treatment.
Endovascular treatment of acute ischemic stroke is performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association.It includes thrombectomy, intra-arterial thrombolysis, thrombus aspiration, stenting and balloon angioplasty.

Sham Comparator: Sham group
Sham RIC (remote ischemic conditioning) paired with endovascular treatment.
Procedure: Endovascular treatment.
Endovascular treatment of acute ischemic stroke is performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association.It includes thrombectomy, intra-arterial thrombolysis, thrombus aspiration, stenting and balloon angioplasty.

Device: Sham remote ischemic conditioning
Sham RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on unilateral arms and inflated to 60 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeately for 4 times.
Other Name: Sham RIC




Primary Outcome Measures :
  1. Final cerebral infarct volume. [ Time Frame: 3-7 days after stroke onset. ]
    The final infarct volume of cerebral infarct is evaluated by cranial noncontrast CT.


Secondary Outcome Measures :
  1. The proportion of enrolled subjects that completed all the designed RIC procedures. [ Time Frame: 0-3 days. ]
    5 times of RIC or sham RIC interventions are planned to be applied to each subject pre and post-endovascular treatment.

  2. The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS). [ Time Frame: 0-90 days. ]
    The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).

  3. Change in NIHSS. [ Time Frame: 0-90 days. ]
    NIHSS will be assessed by certified study investigator who are blind to the treatment assignment at baseline (pre-operation), 24±6 hrs, 5 to 7 days or discharge if earlier, and 90±7 days post-recanalization.

  4. Symptomatic Intracerebral Hemorrhage. [ Time Frame: 0-90 days. ]
    Deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in imaging scans.

  5. Safety - Assessment of adverse events and serious adverse events. [ Time Frame: 0-90 days. ]
    Assessment of adverse events and serious adverse events.



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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. Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization;
  2. Suspected proximal anterior circulation occlusion, and baseline Cincinnati Prehospital Stroke Severity Scale (CPSSS) score≥2;
  3. No remarkable pre-stroke functional disability (mRS ≤ 1);
  4. Baseline NIHSS score obtained prior to randomization must be ≥6;
  5. Age ≥18 and ≤ 80;
  6. Patient treatable within 6 hours of symptom onset;
  7. Informed consent obtained from patient or acceptable patient's surrogate

Exclusion Criteria:

  1. Identified hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0;
  2. Baseline platelet count < 30*109/L;
  3. Baseline blood glucose of < 2.7mmol/L or >22.2mmol/L;
  4. Renal insufficiency with creatinine ≥ 265 umol/L;
  5. Severe, sustained hypertension (SBP > 185 mmHg or DBP > 110 mmHg);
  6. Rapidly improving symptoms at the discretion of the investigator;
  7. Seizures at stroke onset which would preclude obtaining a baseline NIHSS;
  8. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year;
  9. History of life threatening allergy to contrast medium, Nickel, Titanium metals or their alloys;
  10. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission;
  11. Subject participating in a study involving other drug or device trial study;
  12. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations;
  13. Unlikely to be available for 90-day follow-up;
  14. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
  15. Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of <7 on noncontrast CT or <6 on DWI MRI;
  16. CT or MRI evidence of hemorrhage;
  17. Significant mass effect with midline shift on CT or MRI scans;
  18. Angiogram shows arterial tortuosity, pre-existing stent, and/or other arterial disease, which would prevent the device from reaching the target vessel and/or preclude safe recovery of the device;
  19. Subjects with artery occlusions in multiple vascular territories;
  20. Evidence of intracranial tumor.

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): NCT03045055


Contacts
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Contact: Xunming Ji, MD PhD 861013120136877 jixunming@vip.163.com; zhaowb.cmu@qq.com
Contact: Wenbo Zhao, MD Candidate 861015810766407 zhaowb.cool@163.com

Sponsors and Collaborators
Capital Medical University

Publications:

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Responsible Party: Ji Xunming, Professor, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03045055    
Other Study ID Numbers: RIC-AIS
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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, Xuanwu Hospital, Beijing:
Acute ischemic stroke
Endovascular treatment
Remote ischemic conditioning
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes