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Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke (REVISE-1)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210051
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Ji Xunming, Capital Medical University

Brief Summary:

Currently, early reperfusion is considered as the most effective therapy for the treatment of acute ischemic stroke (AIS). Over the past 20 years, intravenous tissue plasminogen activator (IV tPA) has been demonstrated to be the only effective therapy for AIS. More recently, several large randomized clinical trials have concluded the superiority of endovascular mechanical thrombectomy for AIS. Furthermore, with the development of materials and techniques, the occluded artery can be recanalized with high percentage (60%-90%), and the rate of recanalization is still being improved. A great number of AIS patients are now eligible for revascularization therapy and there should be a good prognosis of AIS after recanalizing the occluded artery using mechanical thrombectomy. However, things are never as simple as wished to be. The rate of patients with functional independence is less than 50% and over 15% patients died at 3 months post thrombectomy. The discrepancy between the functional outcome and recanalization rates encourage researchers to explore strategies that further improving the functional outcome of AIS patients.

Remote ischemic conditioning has been demonstrated to reduce cerebral infarct size in mouse model of focal cerebral ischemia. And clinical researches demonstrated the protective effects of remote ischemic conditioning in AIS patient treated with IV tPA,. However, whether remote ischemic conditioning is safe and effective in protecting patients with large-vessel ischemic stroke and undergoing endovascular treatment is still unknown.


Condition or disease Intervention/treatment Phase
Acute Stroke Device: Remote ischemic conditioning Procedure: Endovascular treatment Phase 1

Detailed Description:
In the present study, the investigators will assess the safety and feasibility of remote ischemic condition paired with endovascular treatment for AIS. A single arm of AIS patients treated with endovascular therapy will be recruited, and remote ischemic conditioning will be applied prior to reperfusion therapy and in combination with post reperfusion therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Pilot Study Assessing the Safety and Feasibility of Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke
Actual Study Start Date : July 7, 2017
Actual Primary Completion Date : September 17, 2017
Actual Study Completion Date : December 20, 2017

Arm Intervention/treatment
Experimental: RIC & ET
Remote ischemic conditioning paired with endovascular treatment. RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times. 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: Remote ischemic conditioning
RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.
Other Name: RIC

Procedure: Endovascular treatment
Endovascular treatment include strategies that used to recanalize the occluded artery. Strategies often used include thrombectomy, intra-arterial thrombolysis, stenting and balloon angiography.
Other Name: ET




Primary Outcome Measures :
  1. Number of participants with any RIC-related adverse events. [ Time Frame: 0-90 days after endovascular treatment. ]
    For all participants, adverse events will be assessed by as assessed by CTCAE v4.0.


Secondary Outcome Measures :
  1. Change in cerebral artery blood flow velocity [ Time Frame: 0-7 days. ]
    Cerebral artery blood flow velocity is recorded continuously by Transcranial Doppler (TCD) during remote ischemic conditioning.

  2. Change in vital signs [ Time Frame: 0-7 days. ]
    Vital signs are documented continuously during remote ischemic conditioning.

  3. Change in intracranial pressure [ Time Frame: 0-7 days. ]
    Intracranial pressure is monitored by noninvasive intracranial pressure monitoring equipment during remote ischemic conditioning

  4. Change in plasma biomarkers [ Time Frame: 0-7 days. ]
    Plasma biomarkers include biochemical biomarkers (e.g.,creatine kinase), blood routine test and coagulation function (e.g., PT, APTT, TT).

  5. Final cerebral infarct volume. [ Time Frame: 5-9 days after endovascular treatment. ]
    The final infarct volume of cerebral infarct is evaluated by cranial noncontrast CT.

  6. Number of subjects completing all the designed RIC procedures. [ Time Frame: 0-7 days. ]
    9 times (36 cycles) of RIC interventions are planned to be applied to each subject pre and post-endovascular treatment for 7 consecutive days.

  7. 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).

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

  9. Any adverse event. [ Time Frame: 0-90 days. ]
    Adverse events related or not related to remote ischemic conditioning will be documented.



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Ages Eligible for Study:   18 Years to 90 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. No remarkable pre-stroke functional disability (mRS ≤ 1);
  3. Age ≥18 and ≤ 80;
  4. Patient treatable within six hours of symptom onset;
  5. 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. Woman of childbearing potential who is known to be pregnant or lactating;
  7. Subject participating in a study involving other drug or device trial study;
  8. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations;
  9. Unlikely to be available for 90-day follow-up;
  10. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
  11. Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of <7 on noncontrast CT;
  12. CT or MRI evidence of hemorrhage;
  13. Significant mass effect with midline shift on CT or MRI scans;
  14. Subjects with artery occlusions in multiple vascular territories;
  15. 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): NCT03210051


Locations
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China
Xuanwu Hospital, Capital Medical University
Beijing, China, 100053
Sponsors and Collaborators
Capital Medical University
Publications:
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Responsible Party: Ji Xunming, Clinical Professor, Principal Investigator, Capital Medical University
ClinicalTrials.gov Identifier: NCT03210051    
Other Study ID Numbers: RIC-AIS-1
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Capital Medical University:
Acute ischemic stroke
Endovascular treatment
Remote ischemic conditioning
Reperfusion therapy
Neuroprotection
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