Acute Ischemic StrokeRICASONCT06823128
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Severe Stenosis or Occlusion of Anterior Intracranial Circulation Vessels
A study testing RIC and Guideline-based therapy in people with Acute Ischemic Stroke, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
Trial summary
The primary purpose of this study is to examine whether remote ischemic treatment can better the 90 - day neurological outcomes in acute ischemic stroke patients having severe stenosis or occlusion of anterior intracranial circulation vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- RIC and Guideline-based therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 458 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2025to 28 Feb 2026
- 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
- Age is 18 years old or above.
- Severe stenosis (70% - 99%) or occlusion of anterior intracranial circulation vessels, mainly including the intracranial segment of the internal carotid artery, middle cerebral artery (M1, M2) and anterior cerebral artery (A1, A2), which is confirmed by digital subtraction angiography (DSA), computed tomography angiography (CTA) or magnetic resonance angiography (MRA).
- Patients with clinically diagnosed acute ischemic stroke who received remote ischemic treatment within 72 hours after the onset.
- The NIHSS score ranges from 4 to 24.
- The mRS score before stroke is less than or equal to 1.
- informed consent.
Who cannot join
- Patients with vessel recanalization after mechanical thrombectomy (TICI grade ≥ 2b).
- Patients planning to receive intracranial endovascular treatment within 3 months.
- Patients diagnosed with acute posterior circulation cerebral infarction.
- Symptoms caused by non - culprit vessels.
- Ipsilateral extracranial vessel stenosis ≥ 70%.
- Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and uncontrollable by antihypertensive drugs.
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- Intracranial tumors, arteriovenous malformations or aneurysms.
- Cerebral venous thrombosis or stenosis.
- Severe coagulation abnormalities.
- Any contraindications to remote ischemic conditioning: severe soft tissue injury, fracture or vascular injury of the upper limb, perivascular lesions of the distal upper limb, etc.
- Patients with any serious diseases and a life expectancy of less than 1 year.
- Patients who participated in other clinical trials within 3 months before enrollment or are currently participating in other clinical trials.
- Patients who cannot be followed up (such as those without a fixed residence, overseas patients, etc.).
- Pregnant or lactating women.
- Patients who have previously received remote ischemic treatment or similar treatments.
- Patients whom the researchers consider unsuitable for this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of University of Science and Technology of China
Hefei
About this study
The primary purpose of this study is to examine whether remote ischemic treatment can better the 90 - day neurological outcomes in acute ischemic stroke patients having severe stenosis or occlusion of anterior intracranial circulation vessels.
- Conditions
- Acute Ischemic Stroke
- Being tested
- RIC, Sham, Guideline-based therapy
- Keywords
- Remote ischemic conditioning, anterior circulation, Acute Ischemic Stroke, Occlusion, stenosis
- Medical subject headings
- Ischemic Stroke, Bites and Stings, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RICDevice
Remote Ischemic Conditioning is given twice a day with 200mmHg pressure,last for 7 to 10 days.
ShamDevice
RIC is given twice a day with 60mmHg pressure, last for 7 to 10 days.
Guideline-based therapyOther
Guideline-based therapy
| Study group | Role | What they receive |
|---|---|---|
| RIC group+Guideline-based therapy | Experimental | RIC is given twice a day with 200mmHg pressure. Receives: Device: RIC; Other: Guideline-based therapy |
| Sham group+Guideline-based therapy | Active comparator | RIC is given twice a day with 60mmHg pressure. Receives: Device: Sham; Other: Guideline-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of 90-day mRS scores
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
Measured: 90±14 days after procedure
Secondary outcomes (8)
Distribution of 360-day mRS scores (to be analyzed separately in the subsequent study)
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
Measured: 90±14 days after procedure
Proportion of patients with functional independence outcome (mRS 0-1) at 90-day
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: 90 (± 14 days) after procedure
Proportion of patients with functional independence outcome (mRS 0-2) at 90-day
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: 90 (± 14 days) after procedure
Proportion of patients with functional independence outcome (mRS 0-3) at 90-day
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: 90 (± 14 days) after procedure
The proportion of early neurological deterioration
It is defined as an increase of ≥ 2 points in the NIHSS score on the 7th day compared to the baseline (excluding intracerebral hemorrhage).
Measured: 7 (± 1 day) after procedure
Activities of Daily Living of Participants Assessed by Bathel Index at 90-day
10 rating items, each of which is categorized into 2-3 out of 5 levels: Unable, Needs major help, Needs help, Needs minor help, and Independent, and each item has a different score for each level. Independence was positively correlated with the final score.
Measured: 90 (± 14 days) after procedure
Activities of Daily Living of Participants Assessed by Bathel Index at 360-day
10 rating items, each of which is categorized into 2-3 out of 5 levels: Unable, Needs major help, Needs help, Needs minor help, and Independent, and each item has a different score for each level. Independence was positively correlated with the final score.
Measured: 360(± 14 days) after procedure
Incidences of adverse cardiovascular and cerebrovascular events, and recurrent ischemic events
Adverse cardiovascular and cerebrovascular events include myocardial infarction, heart failure, severe arrhythmia, cerebral infarction, cerebral hemorrhage, transient ischemic attack (TIA), and recurrent ischemic events include recurrent myocardial infarction and recurrent cerebral infarction.
Measured: 360 (± 14 days) after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start5 Apr 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Why it stopped: The reason for the early termination is that the results of the mediation analysis are inconclusive.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Hu, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823128
- Sponsor's protocol ID
- RICASO
- Acronym
- RICASO
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remote Ischemic Conditioning in Patients With Severe Stenosis or Occlusion of Anterior Intracranial Circulation Vessels
- ClinicalTrials.gov ID
- NCT06823128
- Acronym / sponsor ID
- RICASO / RICASO
- Conditions
- Acute Ischemic Stroke
- Keywords
- Remote ischemic conditioning, anterior circulation, Acute Ischemic Stroke, Occlusion, stenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The reason for the early termination is that the results of the mediation analysis are inconclusive.
- Enrolment
- 458 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of ChinaUniversity, hospital or other
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 12 Feb 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.
The primary purpose of this study is to examine whether remote ischemic treatment can better the 90 - day neurological outcomes in acute ischemic stroke patients having severe stenosis or occlusion of anterior intracranial circulation vessels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group+Guideline-based therapy | Experimental | Device: RIC, Other: Guideline-based therapyRIC is given twice a day with 200mmHg pressure. |
| Sham group+Guideline-based therapy | Active comparator | Device: Sham, Other: Guideline-based therapyRIC is given twice a day with 60mmHg pressure. |
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 is 18 years old or above.
- Severe stenosis (70% - 99%) or occlusion of anterior intracranial circulation vessels, mainly including the intracranial segment of the internal carotid artery, middle cerebral artery (M1, M2) and anterior cerebral artery (A1, A2), which is confirmed by digital subtraction angiography (DSA), computed tomography angiography (CTA) or magnetic resonance angiography (MRA).
- Patients with clinically diagnosed acute ischemic stroke who received remote ischemic treatment within 72 hours after the onset.
- The NIHSS score ranges from 4 to 24.
- The mRS score before stroke is less than or equal to 1.
Key exclusion criteria (16 listed)
- Patients with vessel recanalization after mechanical thrombectomy (TICI grade ≥ 2b).
- Patients planning to receive intracranial endovascular treatment within 3 months.
- Patients diagnosed with acute posterior circulation cerebral infarction.
- Symptoms caused by non - culprit vessels.
- Ipsilateral extracranial vessel stenosis ≥ 70%.
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 |
|---|---|---|
| RICRemote Ischemic Conditioning is given twice a day with 200mmHg pressure,last for 7 to 10 days. | Device | RIC group+Guideline-based therapy |
| ShamRIC is given twice a day with 60mmHg pressure, last for 7 to 10 days. | Device | Sham group+Guideline-based therapy |
| Guideline-based therapyGuideline-based therapy | Other | RIC group+Guideline-based therapy, Sham group+Guideline-based therapy |
Primary outcome
Distribution of 90-day mRS scores
Time frame: 90±14 days after procedure
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
8 secondary outcomes
Distribution of 360-day mRS scores (to be analyzed separately in the subsequent study)
Time frame: 90±14 days after procedure
Proportion of patients with functional independence outcome (mRS 0-1) at 90-day
Time frame: 90 (± 14 days) after procedure
Proportion of patients with functional independence outcome (mRS 0-2) at 90-day
Time frame: 90 (± 14 days) after procedure
Proportion of patients with functional independence outcome (mRS 0-3) at 90-day
Time frame: 90 (± 14 days) after procedure
The proportion of early neurological deterioration
Time frame: 7 (± 1 day) after procedure
Activities of Daily Living of Participants Assessed by Bathel Index at 90-day
Time frame: 90 (± 14 days) after procedure
Activities of Daily Living of Participants Assessed by Bathel Index at 360-day
Time frame: 360(± 14 days) after procedure
Incidences of adverse cardiovascular and cerebrovascular events, and recurrent ischemic events
Time frame: 360 (± 14 days) after procedure
Results and safety
The study was stopped early (reason given: The reason for the early termination is that the results of the mediation analysis are inconclusive.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIC and Guideline-based therapy in people with Acute Ischemic Stroke, run by The First Affiliated Hospital of University of Science and Technology of China 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 16 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: stopped early, as of the sponsor's last update on 10 Jun 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?
The study was stopped early (reason given: The reason for the early termination is that the results of the mediation analysis are inconclusive.). Results are not available in the source record.
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?
Distribution of 90-day mRS scores (time frame: 90±14 days after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2026.