CompletedNCT03210051Updated Dec 22, 2017

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

A Phase 1 interventional study of Remote ischemic conditioning and Endovascular treatment in Acute Stroke, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-12-22.

Sponsored by Capital Medical University · Phase 1, Interventional, and Device feasibility

Phase: Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 18 Years to 90 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Acute Stroke

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Keywords

Acute ischemic stroke
Endovascular treatment
Remote ischemic conditioning
Reperfusion therapy
Neuroprotection

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 5,482 interventional studies indexed under Stroke.

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Lead sponsor

Capital Medical University is the lead sponsor of 293 studies on the registry; 91 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 1
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

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 · Procedure: Endovascular treatment

Interventions

DeviceRemote 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.
Also known as: RIC
ProcedureEndovascular treatment
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

What researchers measure

Primary outcomes

Number of participants with any RIC-related adverse events.
For all participants, adverse events will be assessed by as assessed by CTCAE v4.0.
Time frame: 0-90 days after endovascular treatment.

Secondary outcomes

Change in cerebral artery blood flow velocity
Cerebral artery blood flow velocity is recorded continuously by Transcranial Doppler (TCD) during remote ischemic conditioning.
Time frame: 0-7 days.
Change in vital signs
Vital signs are documented continuously during remote ischemic conditioning.
Time frame: 0-7 days.
Change in intracranial pressure
Intracranial pressure is monitored by noninvasive intracranial pressure monitoring equipment during remote ischemic conditioning
Time frame: 0-7 days.
Change in plasma biomarkers
Plasma biomarkers include biochemical biomarkers (e.g.,creatine kinase), blood routine test and coagulation function (e.g., PT, APTT, TT).
Time frame: 0-7 days.
Final cerebral infarct volume.
The final infarct volume of cerebral infarct is evaluated by cranial noncontrast CT.
Time frame: 5-9 days after endovascular treatment.
Number of subjects completing all the designed RIC procedures.
9 times (36 cycles) of RIC interventions are planned to be applied to each subject pre and post-endovascular treatment for 7 consecutive days.
Time frame: 0-7 days.
The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).
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).
Time frame: 0-90 days.
Symptomatic Intracerebral Hemorrhage.
Deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of hemorrhage in imaging scans.
Time frame: 0-90 days.
Any adverse event.
Adverse events related or not related to remote ischemic conditioning will be documented.
Time frame: 0-90 days.

Study locations

1 site

Xuanwu Hospital, Capital Medical University
Beijing, 100053, China

References and documents

Publications

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. PubMed 27766474 ↗
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. PubMed 25868435 ↗
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. PubMed 23035060 ↗

Individual participant data

Plan to share: Undecided

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2017 to primary completion in Sep 2017, 2 months.

Of 62 non-industry phase 1 interventional studies under Stroke, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 53. This study's 2 months is below that.

Counting every sponsor, half of 83 studies reached it within 23 months; a quarter within 12 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 26, 2017
First posted: Jul 6, 2017
StartActual: Jul 7, 2017
Primary completionActual: Sep 17, 2017
CompletionActual: Dec 20, 2017
Last update: Dec 22, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03210051
Lead sponsor: Capital Medical University
Responsible party: Ji Xunming (Clinical Professor, Principal Investigator, Capital Medical University) — Principal investigator
First posted: Jul 6, 2017
Start date: Jul 7, 2017
Primary completion: Sep 17, 2017
Completion: Dec 20, 2017
Last update: Dec 22, 2017

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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