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

NCT03210051 | Completed Phase 1

• 1 other identifier: RIC-AIS-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke

Keywords

Acute ischemic stroke; Endovascular treatment; Remote ischemic conditioning; Reperfusion therapy; Neuroprotection

Outcome Measures

Primary Outcomes (1)

• Number of participants with any RIC-related adverse events.

  For all participants, adverse events will be assessed by as assessed by CTCAE v4.0.

  0-90 days after endovascular treatment.

Secondary Outcomes (9)

• Change in cerebral artery blood flow velocity

  0-7 days.

• Change in vital signs

  0-7 days.

• Change in intracranial pressure

  0-7 days.

• Change in plasma biomarkers

  0-7 days.

• Final cerebral infarct volume.

  5-9 days after endovascular treatment.

Study Arms (1)

RIC & ET

EXPERIMENTAL

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; Procedure: Endovascular treatment

Interventions

Remote ischemic conditioning DEVICE

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.

Also known as: RIC

RIC & ET

Endovascular treatment PROCEDURE

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

Also known as: ET

RIC & ET

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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;
• No remarkable pre-stroke functional disability (mRS ≤ 1);
• Age ≥18 and ≤ 80;
• Patient treatable within six 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);
• Woman of childbearing potential who is known to be pregnant or lactating;
• 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;
• CT or MRI evidence of hemorrhage;
• Significant mass effect with midline shift on CT or MRI scans;
• Subjects with artery occlusions in multiple vascular territories;
• Evidence of intracranial tumor.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

Related Publications (3)

• 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: 27766474 BACKGROUND

• Ren C, Wang P, Wang B, Li N, Li W, Zhang C, Jin K, Ji X. Limb remote ischemic per-conditioning in combination with post-conditioning reduces brain damage and promotes neuroglobin expression in the rat brain after ischemic stroke. Restor Neurol Neurosci. 2015;33(3):369-79. doi: 10.3233/RNN-140413.

  PMID: 25868435 BACKGROUND

• Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.

  PMID: 23035060 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Principal Investigator

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 6, 2017
• Study Start: July 7, 2017
• Primary Completion: September 17, 2017
• Study Completion: December 20, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Locations

CN (1)