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StrokeRICAMISNCT03740971

Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke

A study testing Remote Ischemic Conditioning treatment and Guideline-based therapy in people with Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The current treatment based on evidence-based medicine for acute ischemic stroke mainly includes reperfusion (intravenous thrombolysis, mechanical thrombolysis), anti-platelet and stroke units. About 1/3 patients can obtain good prognosis through intravenous thrombolysis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Remote Ischemic Conditioning treatment and Guideline-based therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,800 participants
Where
1 siteChina
Study dates
26 Dec 2018to 19 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient age ≥18 years;
  • From onset to treatment ≤ 48 hours;
  • Ischemic stroke confirmed by head CT or MRI;
  • 6≤NIHSS score ≤ 16;
  • Premorbid mRS ≤ 1;
  • Signed informed consent.

Who cannot join

  • Serious neurological deficits before onset ( mRS ≥ 2)；
  • The aetiology of cardiogenic embolism, such as rheumatic mitral or aortic stenosis, artificial heart valve, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, left ventricular wall thrombus or valve neoplasm, congestive heart failure, bacterial endocarditis, etc;
  • Uncontrolled severe hypertension (Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg after drug treatment);
  • Subclavian artery stenosis ≥ 50% or subclavian steal syndrome;
  • Intracranial tumor, arteriovenous malformation or aneurysm;
  • Severe abnormalities in coagulation;
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  • Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.;
  • Comorbidity with any serious diseases and life expectancy is less than half a year;
  • Participating in other clinical trials within 3 months;
  • Patients not suitable for this clinical studies considered by researcher;

Trial locations and contacts

1 site in 1 country.

China1 site

  • General Hospital of ShenYang Military Region

    Shenyang

Other trials in China

About this study

Official title: Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke (RICAMIS): a Prospective, Random, Open Label, Blinded End Point, Multi-center Study

The current treatment based on evidence-based medicine for acute ischemic stroke mainly includes reperfusion (intravenous thrombolysis, mechanical thrombolysis), anti-platelet and stroke units. About 1/3 patients can obtain good prognosis through intravenous thrombolysis. Good prognosis can be gotten from about 50 percent of patients with big artery disease by mechanical embolization. However, only a small proportion of the population can be treated with restoration perfusion in the time window. The main purpose of antiplatelet therapy is to prevent the recurrence and progression of stroke, and stroke unit is a kind of management mode. How to improve the neurological function of patients has been a hot and difficult problem in clinical practice.

A large number of basic and clinical studies have proved that remote ischemic conditioning (RIC) has protective effect on ischemic stroke. Hahn et al showed that RIC could play a neuroprotective role in cerebral ischemia-reperfusion injury in MCAO model. Other studies have also confirmed that preconditioning RIC has a neuroprotective effect on cerebral ischemia in animal models. One open label study by Hougaard et al shows that RIC can improve the NIHSS score in acute ischemic stroke patients. One recent study found that 300 consecutive days RIC therapy for the patients with symptomatic intracranial atherosclerotic stenosis significantly reduced the recurrence rate of stroke, improved the mRS score and recovered the blood flow in the lesion site. Furthermore, several studies have also shown that RIC can not only improve the neurological function of patients with cerebral infarction after intravenous thrombolysis and mechanical thrombolysis, but also protect the secondary brain injury after carotid stenting. These results suggest that RIC has a neuroprotective effect on ischemic stroke and deserves further study.

Based on the above discussion, this study aims to explore the efficacy and safety of RIC in the treatment of acute moderate ischemic stroke.

Conditions
Stroke
Being tested
Remote Ischemic Conditioning treatment, Guideline-based therapy
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote Ischemic Conditioning treatmentDevice

    Remote Ischemic Conditioning is given twice a day with 200mmHg pressure.

  • Guideline-based therapyDrug

    Guideline-based therapy

Study groups in NCT03740971
Study groupRoleWhat they receive
Guideline-based therapy+RICExperimentalRIC is given twice a day with 200mmHg pressure.
Receives: Device: Remote Ischemic Conditioning treatment
Guideline-based therapyActive comparatorNot described
Receives: Drug: Guideline-based therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of mRS (0-1）

    Measured: 90±7 days

Secondary outcomes (5)

  1. Proportion of mRS (0-2）

    Measured: 90±7 days

  2. Incidence of early neurological deterioration

    more than 4 NIHSS score increase compared with baseline

    Measured: 7 days

  3. Incidence of stroke associated pneumonia

    Measured: 12±2 days

  4. occurrence of stroke or other vascular events

    Measured: 90±7 days

  5. proportion of death of any cause

    Measured: 90±7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2018
  2. Study start26 Dec 2018
  3. Primary completion19 Apr 2021
  4. Study completion19 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03740971
Sponsor's protocol ID
k（2018）43
Acronym
RICAMIS
Status last verified
May 2021
First submitted
12 Nov 2018
Last updated
5 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • He XY, Cui Y, Wang JQ, Wang L, Chen HS. Renal Function and Efficacy of Remote Ischemic Conditioning in Acute Moderate Ischemic Stroke: A Post Hoc Analysis of RICAMIS Trial. Brain Behav. 2025 Oct;15(10):e70831. doi: 10.1002/brb3.70831.

    PubMed 41058191

  • Zhang XW, Cui Y, Chen HS. Smoking status and the efficacy of remote ischaemic conditioning: a secondary analysis of the RICAMIS trial. Stroke Vasc Neurol. 2026 Apr 27;11(2):182-190. doi: 10.1136/svn-2025-004349.

    PubMed 40830061

  • Cui Y, Cui LY, Chi X, Wang Q, Zhang XW, Chen HS. Platelet-to-Neutrophil Ratio and Efficacy of Remote Ischemic Conditioning in Acute Ischemic Stroke. PLoS One. 2025 Jul 3;20(7):e0322037. doi: 10.1371/journal.pone.0322037. eCollection 2025.

    PubMed 40608686

  • Sun XY, Qu HL, Chen HS. Body mass index and remote ischaemic conditioning efficacy in acute ischaemic stroke patients: A post hoc analysis of the Remote Ischaemic Conditioning for Acute Moderate Ischaemic Stroke (RICAMIS) trial. Diabetes Obes Metab. 2024 Jul;26(7):2993-2996. doi: 10.1111/dom.15614. Epub 2024 Apr 28. No abstract available.

    PubMed 38680037

  • Cui Y, Wang XH, Shang ZY, Wang L, Chen HS. Baseline neurologic deficit and efficacy of remote ischemic conditioning after acute ischemic stroke: A post hoc analysis of RICAMIS. Neurotherapeutics. 2024 Jan;21(1):e00294. doi: 10.1016/j.neurot.2023.10.004. Epub 2023 Dec 19.

    PubMed 38241163

  • Cui Y, Yuan ZM, Liu QY, Wang YJ, Chen HS. Remote Ischemic Conditioning and Outcomes in Acute Ischemic Stroke With Versus Without Large Artery Atherosclerosis. Stroke. 2023 Dec;54(12):3165-3168. doi: 10.1161/STROKEAHA.123.045040. Epub 2023 Oct 18.

    PubMed 37850359

  • Chen HS, Cui Y, Li XQ, Wang XH, Ma YT, Zhao Y, Han J, Deng CQ, Hong M, Bao Y, Zhao LH, Yan TG, Zou RL, Wang H, Li Z, Wan LS, Zhang L, Wang LQ, Guo LY, Li MN, Wang DQ, Zhang Q, Chang DW, Zhang HL, Sun J, Meng C, Zhang ZH, Shen LY, Ma L, Wang GC, Li RH, Zhang L, Bi C, Wang LY, Wang DL; RICAMIS Investigators. Effect of Remote Ischemic Conditioning vs Usual Care on Neurologic Function in Patients With Acute Moderate Ischemic Stroke: The RICAMIS Randomized Clinical Trial. JAMA. 2022 Aug 16;328(7):627-636. doi: 10.1001/jama.2022.13123.

    PubMed 35972485

Questions about this trial

What is this clinical trial studying?

A study testing Remote Ischemic Conditioning treatment and Guideline-based therapy in people with Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of mRS (0-1） (time frame: 90±7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03740971, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.

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