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

July 23, 2020 updated by: Ji Xunming,MD,PhD, Capital Medical University

A Proof-of-Concept Study Assessing the Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke Patients Undergoing Endovascular Treatment

Ischemic stroke, which is due to the occlusion of a cerebral blood vessel, comprises nearly 80-90% 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;
  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 24 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RIC group
RIC (remote ischemic conditioning) paired with endovascular treatment.
Device: Remote ischemic conditioning.
The RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days.
Other Names:
  • 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
The sham RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 30 mmHg during the ischemia period. Sham RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days.
Other Names:
  • Sham RIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral infarction volume.
Time Frame: 7 days after stroke onset.
The cerebral infarction volume is evaluated on cerebral imaging.
7 days after stroke onset.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
0-90 days.
The proportion of enrolled subjects that completed all the designed RIC procedures.
Time Frame: 0-7 days.
Nine times of RIC or sham RIC interventions are planned to be applied to each subject pre and post-endovascular treatment.
0-7 days.
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.
0-90 days.
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.
0-90 days.
Safety - Assessment of adverse events and serious adverse events.
Time Frame: 0-90 days.
Assessment of adverse events and serious adverse events.
0-90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Collaborators

Shengli Oilfield Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

February 3, 2017

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REVISE-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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