Ischemic StrokeRICAMIS2NCT06931535
Remote Ischemic Conditioning for Acute Moderate Posterior Ischemic Stroke
A study testing remote ischemic conditioning in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
A substantial body of basic and clinical research has demonstrated the protective effects of remote ischemic conditioning (RIC) in ischemic stroke. While these clinical studies support the safety of RIC, the neuroprotective benefits of RIC in acute ischemic stroke (AIS) patients lack robust evidence due to small… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years;
- Time from onset to treatment: ≤48 hours;
- Posterior circulation ischemic stroke confirmed by CT or MRI, including patients who have received intravenous thrombolysis or endovascular therapy;
- NIHSS score at randomization: 6-16, with an item 1a (level of consciousness) score of 0-1;
- First-ever stroke or prior stroke without significant residual disability (modified Rankin Scale score ≤1);
- Signed informed consent.
Who cannot join
- intracerebral hemorrhage or subarachnoid hemorrhage；
- Uncontrolled severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg despite antihypertensive therapy)；
- Subclavian artery stenosis ≥ 50% or subclavian steal syndrome;
- Intracranial tumor, arteriovenous malformation or aneurysm;
- Severe abnormalities in coagulation;
- Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.;
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- Participating in other clinical trials within 3 months;
- Comorbidity with any serious diseases and life expectancy is less than half a year;
- Patients not suitable for this clinical studies considered by researcher;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
Hui-Sheng Chen, Ph.D., +86 13352452086, chszh@aliyun.com
About this study
Official title: Remote Ischemic Conditioning for Acute Moderate Posterior Ischemic Stroke (RICAMIS2): a Prospective, Random, Open Label, Blinded End Point, Multi-center Study
A substantial body of basic and clinical research has demonstrated the protective effects of remote ischemic conditioning (RIC) in ischemic stroke. While these clinical studies support the safety of RIC, the neuroprotective benefits of RIC in acute ischemic stroke (AIS) patients lack robust evidence due to small sample sizes, heterogeneous RIC protocols, and variability in the severity of neurological deficits among study populations. Our recent multicenter randomized clinical trial, the RICAMIS study, investigated the efficacy of RIC in patients with acute moderate ischemic stroke. The results showed that RIC administered within 48 hours of onset significantly improved 90-day neurological outcomes in patients with moderate stroke severity. It is well established that anterior circulation stroke (ACS) and posterior circulation stroke (PCS) differ in multiple aspects, including anatomical structure, collateral circulation, blood supply, clinical manifestations, prognosis, ischemic tolerance time, and treatment response. For instance, compared to the anterior circulation, the posterior circulation has poorer collateral circulation, a higher proportion of stroke etiologies attributed to atherosclerosis, and longer ischemic tolerance time. Consequently, intravenous thrombolysis and endovascular therapy may offer a more extended therapeutic time window for PCS patients. A prespecified subgroup analysis of the RICAMIS study revealed that patients with PCS derived greater benefit from RIC than those with ACS. However, this finding requires further validation through prospective studies, as prior research has never specifically examined the efficacy of RIC in PCS patients.
Based on the above discussion, this study aims to investigate the efficacy and safety of RIC in patients with acute moderate PCS.
- Conditions
- Ischemic Stroke
- Being tested
- remote ischemic conditioning
- Keywords
- posterior circulation stroke, remote ischemic conditioning
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic conditioningDevice
The cuff of the remote ischemic conditioning device was placed on both upper arms (at the same position as blood pressure measurement) and inflated to 200 mmHg. The treatment protocol consisted of 5 cycles of 5-minute inflation followed by 5-minute deflation, performed twice daily. The treatment duration was 8-12 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | standard stroke care |
| RIC group | Experimental | remote ischemic conditioning, twice a day, for 10 days. Receives: Device: remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of excellent outcome
Excellent outcome is defined as modified Rankin Scale (mRS) score of 0-1. mRS ranges from 0-6, higher scores mean a worse outcome
Measured: 90±7 days
Secondary outcomes (7)
proportion of favorable outcome
Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2. mRS ranges from 0-6, higher scores mean a worse outcome
Measured: 90±7 days
Distribution of modified Rankin Scale (mRS)
mRS scores range from 0 to 6. mRS ranges from 0-6, higher scores mean a worse outcome.
Measured: 90±7 days
change in National Institute of Health stroke scale (NIHSS)
NIHSS scores range 0-42, with higher scores indicating greater stroke severity
Measured: 24±6 hours
change in National Institute of Health stroke scale (NIHSS)
NIHSS scores range 0-42, with higher scores indicating greater stroke severity
Measured: 10±2 days
The incidence of stroke-associated pneumonia (SAP)
SAP is defined according to the recommendation from the pneumonia in stroke consensus group (Stroke. 2015; 46:2335-40.)
Measured: 10±2 days or during hospitalization, whichever is earlier.
occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events
Measured: 90±7 days
death due to all causes
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.
- First posted17 Apr 2025
- Study start13 Apr 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931535
- Sponsor's protocol ID
- Y (2024) 345
- Acronym
- RICAMIS2
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu QY, Li X, Dai YJ, Zhou ZH, Chen HS. Remote ischaemic conditioning for acute moderate posterior ischaemic stroke (RICAMIS2): rationale and design. Stroke Vasc Neurol. 2026 Sep 30:svn-2025-004552. doi: 10.1136/svn-2025-004552. Online ahead of print.
PubMed 42816113
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning for Acute Moderate Posterior Ischemic Stroke (RICAMIS2): a Prospective, Random, Open Label, Blinded End Point, Multi-center Study
- ClinicalTrials.gov ID
- NCT06931535
- Acronym / sponsor ID
- RICAMIS2 / Y (2024) 345
- Conditions
- Ischemic Stroke
- Keywords
- posterior circulation stroke, remote ischemic conditioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 13 Apr 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A substantial body of basic and clinical research has demonstrated the protective effects of remote ischemic conditioning (RIC) in ischemic stroke. While these clinical studies support the safety of RIC, the neuroprotective benefits of RIC in acute ischemic stroke (AIS) patients lack robust evidence due to small sample sizes, heterogeneous RIC protocols, and variability in the severity of neurological deficits among study populations. Our recent multicenter randomized clinical trial, the RICAMIS study, investigated the efficacy of RIC in patients with acute moderate ischemic stroke. The results showed that RIC administered within 48 hours of onset significantly improved 90-day neurological outcomes in patients with moderate stroke severity. It is well established that anterior circulation stroke (ACS) and posterior circulation stroke (PCS) differ in multiple aspects, including anatomical structure, collateral circulation, blood supply, clinical manifestations, prognosis, ischemic tolerance time, and treatment response. For instance, compared to the anterior circulation, the posterior circulation has poorer collateral circulation, a higher proportion of stroke etiologies attributed to atherosclerosis, and longer ischemic tolerance time. Consequently, intravenous thrombolysis and endovascular therapy may offer a more extended therapeutic time window for PCS patients. A prespecified subgroup analysis of the RICAMIS study revealed that patients with PCS derived greater benefit from RIC than those with ACS. However, this finding requires further validation through prospective studies, as prior research has never specifically examined the efficacy of RIC in PCS patients.
Based on the above discussion, this study aims to investigate the efficacy and safety of RIC in patients with acute moderate PCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –standard stroke care |
| RIC group | Experimental | Device: remote ischemic conditioningremote ischemic conditioning, twice a day, for 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years;
- Time from onset to treatment: ≤48 hours;
- Posterior circulation ischemic stroke confirmed by CT or MRI, including patients who have received intravenous thrombolysis or endovascular therapy;
- NIHSS score at randomization: 6-16, with an item 1a (level of consciousness) score of 0-1;
- First-ever stroke or prior stroke without significant residual disability (modified Rankin Scale score ≤1);
Key exclusion criteria (9 listed)
- intracerebral hemorrhage or subarachnoid hemorrhage；
- Uncontrolled severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg despite antihypertensive therapy)；
- Subclavian artery stenosis ≥ 50% or subclavian steal syndrome;
- Intracranial tumor, arteriovenous malformation or aneurysm;
- Severe abnormalities in coagulation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischemic conditioningThe cuff of the remote ischemic conditioning device was placed on both upper arms (at the same position as blood pressure measurement) and inflated to 200 mmHg. The treatment protocol consisted of 5 cycles of 5-minute inflation followed by 5-minute deflation, performed twice daily. The treatment duration was 8-12 consecutive days. | Device | RIC group |
Primary outcome
proportion of excellent outcome
Time frame: 90±7 days
Excellent outcome is defined as modified Rankin Scale (mRS) score of 0-1. mRS ranges from 0-6, higher scores mean a worse outcome
7 secondary outcomes
proportion of favorable outcome
Time frame: 90±7 days
Distribution of modified Rankin Scale (mRS)
Time frame: 90±7 days
change in National Institute of Health stroke scale (NIHSS)
Time frame: 24±6 hours
change in National Institute of Health stroke scale (NIHSS)
Time frame: 10±2 days
The incidence of stroke-associated pneumonia (SAP)
Time frame: 10±2 days or during hospitalization, whichever is earlier.
occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events
Time frame: 90±7 days
death due to all causes
Time frame: 90±7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 42816113Liu QY, Li X, Dai YJ, Zhou ZH, Chen HS. Remote ischaemic conditioning for acute moderate posterior ischaemic stroke (RICAMIS2): rationale and design. Stroke Vasc Neurol. 2026 Sep 30:svn-2025-004552. doi: 10.1136/svn-2025-004552. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic conditioning in people with Ischemic 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 9 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of excellent outcome (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 NCT06931535, which also lists 1 linked publication.
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 17 Sep 2026.