NCT03045055

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
3.5 years until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

2.4 years

First QC Date

February 3, 2017

Last Update Submit

July 23, 2020

Conditions

Acute Stroke

Keywords

Acute ischemic strokeEndovascular treatmentRemote ischemic conditioning

Outcome Measures

Primary Outcomes (1)

  • Cerebral infarction volume.

    The cerebral infarction volume is evaluated on cerebral imaging.

    7 days after stroke onset.

Secondary Outcomes (5)

  • The proportion of enrolled subjects that completed all the designed RIC procedures.

    0-7 days.

  • The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).

    0-90 days.

  • Change in NIHSS.

    0-90 days.

  • Symptomatic Intracerebral Hemorrhage.

    0-90 days.

  • Safety - Assessment of adverse events and serious adverse events.

    0-90 days.

Study Arms (2)

RIC group

EXPERIMENTAL

RIC (remote ischemic conditioning) paired with endovascular treatment.

Device: Remote ischemic conditioning.Procedure: Endovascular treatment.

Sham group

SHAM COMPARATOR

Sham RIC (remote ischemic conditioning) paired with endovascular treatment.

Procedure: Endovascular treatment.Device: Sham remote ischemic conditioning

Interventions

Remote ischemic conditioning.DEVICE

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.

Also known as: RIC
RIC group
Endovascular treatment.PROCEDURE

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.

RIC groupSham group
Sham remote ischemic conditioningDEVICE

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.

Also known as: Sham RIC
Sham group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • Suspected proximal anterior circulation occlusion;
  • No remarkable pre-stroke functional disability (mRS ≤ 1);
  • Baseline NIHSS score obtained prior to randomization must be ≥6;
  • Age ≥18 and ≤ 80;
  • Patient treatable within 24 hours of symptom onset;
  • Informed consent obtained from patient or acceptable patient's surrogate

You may not qualify if:

  • Identified hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0;
  • Baseline platelet count \< 30\*109/L;
  • Baseline blood glucose of \< 2.7mmol/L or \>22.2mmol/L;
  • Renal insufficiency with creatinine ≥ 265 umol/L;
  • Severe, sustained hypertension (SBP \> 185 mmHg or DBP \> 110 mmHg);
  • Rapidly improving symptoms at the discretion of the investigator;
  • Seizures at stroke onset which would preclude obtaining a baseline NIHSS;
  • Serious, advanced, or terminal illness with anticipated life expectancy of less than one year;
  • History of life threatening allergy to contrast medium, Nickel, Titanium metals or their alloys;
  • Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission;
  • Subject participating in a study involving other drug or device trial study;
  • Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations;
  • Unlikely to be available for 90-day follow-up;
  • Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
  • Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of \<7 on noncontrast CT or \<6 on DWI MRI;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Hausenloy DJ, Barrabes JA, Botker HE, Davidson SM, Di Lisa F, Downey J, Engstrom T, Ferdinandy P, Carbrera-Fuentes HA, Heusch G, Ibanez B, Iliodromitis EK, Inserte J, Jennings R, Kalia N, Kharbanda R, Lecour S, Marber M, Miura T, Ovize M, Perez-Pinzon MA, Piper HM, Przyklenk K, Schmidt MR, Redington A, Ruiz-Meana M, Vilahur G, Vinten-Johansen J, Yellon DM, Garcia-Dorado D. Ischaemic conditioning and targeting reperfusion injury: a 30 year voyage of discovery. Basic Res Cardiol. 2016 Nov;111(6):70. doi: 10.1007/s00395-016-0588-8. Epub 2016 Oct 20.

    PMID: 27766474BACKGROUND

  • Zhao W, Meng R, Ma C, Hou B, Jiao L, Zhu F, Wu W, Shi J, Duan Y, Zhang R, Zhang J, Sun Y, Zhang H, Ling F, Wang Y, Feng W, Ding Y, Ovbiagele B, Ji X. Safety and Efficacy of Remote Ischemic Preconditioning in Patients With Severe Carotid Artery Stenosis Before Carotid Artery Stenting: A Proof-of-Concept, Randomized Controlled Trial. Circulation. 2017 Apr 4;135(14):1325-1335. doi: 10.1161/CIRCULATIONAHA.116.024807. Epub 2017 Feb 7.

    PMID: 28174194BACKGROUND

  • Zhao W, Che R, Li S, Ren C, Li C, Wu C, Lu H, Chen J, Duan J, Meng R, Ji X. Remote ischemic conditioning for acute stroke patients treated with thrombectomy. Ann Clin Transl Neurol. 2018 Jun 6;5(7):850-856. doi: 10.1002/acn3.588. eCollection 2018 Jul.

    PMID: 30009202BACKGROUND

  • Zhao W, Wu C, Dornbos D 3rd, Li S, Song H, Wang Y, Ding Y, Ji X. Multiphase adjuvant neuroprotection: A novel paradigm for improving acute ischemic stroke outcomes. Brain Circ. 2020 Feb 18;6(1):11-18. doi: 10.4103/bc.bc_58_19. eCollection 2020 Jan-Mar.

    PMID: 32166195BACKGROUND

  • Zhao W, Li S, Ren C, Meng R, Jin K, Ji X. Remote ischemic conditioning for stroke: clinical data, challenges, and future directions. Ann Clin Transl Neurol. 2018 Nov 15;6(1):186-196. doi: 10.1002/acn3.691. eCollection 2019 Jan.

    PMID: 30656197BACKGROUND

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Xunming Ji, MD PhD

CONTACT

861013120136877jixunming@vip.163.com; zhaowb.cmu@qq.com

Wenbo Zhao, MD Candidate

CONTACT

861015810766407zhaowb.cool@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 7, 2017

Study Start

August 1, 2020

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

July 27, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share