Stroke, IschemicRICASNCT06170944
Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke
A study testing Remote ischemic preconditioning in people with Stroke, Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Nov 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age over 40 years old;
- 2. Diagnosed with ischemic stroke (including TIA and cerebral infarction), with onset time of more than 1 month;
- 3. Culprit arteries are the large arteries of the anterior circulation with atherosclerotic stenosis (≥50%) or occlusion;
- 4. ASITN/SIR collateral circulation of 0-3 based on DSA evaluation;
- 5. First onset or prior onset with no significant sequelae (mRS ≤ 2);
- 6. Those who are not expected to undergo angioplasty within 12 months (judged by the doctor or decided by patients and/or their representatives);
- 7. The availability of informed consent.
Who cannot join
- 1) Patients with severe infection or serious diseases such as liver, kidney, hematopoietic system, endocrine system, etc.;
- 2) Patients with a history of stroke and severe sequelae (mRS≥3);
- 3) arterial stenosis due to aortic dissection, moyamoya disease; Any known vasculitic disease; herpes zoster, varicella-zoster or other viral infections with vascular lesions; neurosyphilis; other intracranial infections; any intracranial artery stenosis associated with hypercytosis of cerebrospinal fluid; radiation-induced vascular lesions; myofiber dysplasia; sickle cell disease; neurofibromas; benign vascular lesions of the central nervous system; postpartum vascular disease; stenosis of the intracranial arteries due to vasospasm or thrombosm;
- 4) Uncontrolled severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110 mmHg after drug treatment) ;
- 5) Subclavian artery stenosis ≥50% or subclavian artery steal syndrome;
- 6) Patients with intracranial hemorrhage (parenchymal hemorrhage, subarachnoid hemorrhage, subdural/epidural hemorrhage) within 90 days before enrollment;
Show all 17Show fewer
- 7) Intracranial tumor, arteriovenous malformation, or aneurysm;
- 8) Patients with severe hematologic diseases or severe coagulation abnormalities;
- 9) Retinal hemorrhage or visceral hemorrhage within 30 days;
- 10) Those who are expected to undergo major surgery (including femoral artery, cardiac, aortic or carotid artery surgery) within 30 days before enrollment or within 12 months after enrollment;
- 11) Those who have received stent implantation, angioplasty or other related medical devices for the target diseased blood vessels, or those who are expected to undergo the above treatments within 12 months after enrollment;
- 12) Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.
- 13) Damage and lesions in the cerebral veins;
- 14) Pregnant or lactating women;
- 15) Those who are participating in other clinical trials within 3 months;
- 16) Life expectancy is less than 1 year
- 17) 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
General Hospital of Northern Theater Command
Shenyang, 110840
Zi-Ai Zhao, 86-2428897517, zhaoziai@hotmail.com
Yu Cui, 86-24-28897499, cuiyu.spu@hotmail.com
About this study
Official title: Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke (RICAS): a Prospective, Randomized, Blind Endpoint, Multicenter Study
The goal of this clinical trial is to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology.
Read the detailed description
Stroke is the second leading cause of death and the third leading cause of death and disability combined in the world. The remote ischemic preconditioning (RIC) procedure is low-cost with excellent properties of safety, tolerability and feasibility in both AIS and cardiovascular diseases. In this study, we aim to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology. The RICAS study is a prospective, randomized, blind endpoint, multicenter study. Eligible patients with ischemic stroke of anterior circulation with large artery atherosclerosis etiology, poor collateral compensation, and more than 1 month of the symptom onset, are randomly assigned into the experimental group and control group with a ratio of 1:1. The patients in experiment group will receive treatment with RIC for 1 year as an adjunct to guideline-based treatment, while patients in control group only receive guideline-based treatment. The primary outcome is proportion of collateral status improvement, which is defined as an increase of ASITN/SIR score of 1 or more assessed on DSA at 12 months after randomization. The safety outcomes include RIC-related adverse events. A maximum of 300 patients (150 participants per group) are required to test the superiority hypothesis with 80% power (using a two-sided α = 0.05) to detect the 15% difference. The primary endpoint will further be stratified by age, gender, inclusion event (acute ischemic stroke ore transient ischemic stroke), tandem lesion, history of hypertension, hypercholesterolemia, diabetes mellitus, ischemic stroke, transient ischemic attack, and myocardial infarction. This study will provide the direct evidence for improvement of collateral status by chronic RIC treatment.
- Conditions
- Stroke, Ischemic
- Being tested
- Remote ischemic preconditioning
- 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 preconditioningDevice
The patients in experiment group will receive treatment with RIC (5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg) for 1 year as an adjunct to guideline-based treatment.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic preconditioning and guideline-based treatment | Experimental | 5 cycles of cuff inflation (200mmHg for 5 minutes) and deflation (for 5 minutes), once or twice daily for 12 months. Receives: Device: Remote ischemic preconditioning |
| Guideline-based treatment | No intervention | Guideline-based treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of collateral status improvement.
collateral status improvement is defined as an increase of ASITN/SIR score of 1 or more assessed on DSA at 12 months after randomization.
Measured: 12 months
Secondary outcomes (6)
The influence of RIC to neurological functions
Neurological functions was determined by modified Rankin Scale score (0-42, higher scores mean a worse outcome )
Measured: 12 months
Recurrence of nonfatal ischemic stroke in 12 months
Ischemic stroke is diagnosed based on clinical symptom and neuroimaging
Measured: 12 months
Composite vascular events
Composite vascular events include stroke, myocardial infarction, vascular death
Measured: 12 months
Influence on heart function
heart function is assessed by cardiac ultrasound, electrocardiogram, myocardial enzyme profile, etc
Measured: 12 months
Influence on kidney function
kidney function is assessed by glomeruar filtration rate
Measured: 12 months
RIC-related adverse events
include local pain, intolerance, etc.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Jun 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 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 Stroke, IschemicStudies 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
- 300 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
- NCT06170944
- Sponsor's protocol ID
- Y(2023)169
- Acronym
- RICAS
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data dictionary.
Publications
Zhao ZA, Lv Y, Chen HS. Effect of RICAS (Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke): Rationale and Design. J Am Heart Assoc. 2025 Mar 18;14(6):e038570. doi: 10.1161/JAHA.124.038570. Epub 2025 Feb 19.
PubMed 39968799
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke (RICAS): a Prospective, Randomized, Blind Endpoint, Multicenter Study
- ClinicalTrials.gov ID
- NCT06170944
- Acronym / sponsor ID
- RICAS / Y(2023)169
- Conditions
- Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 14 Dec 2023 (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 goal of this clinical trial is to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology.
Detailed description
Stroke is the second leading cause of death and the third leading cause of death and disability combined in the world. The remote ischemic preconditioning (RIC) procedure is low-cost with excellent properties of safety, tolerability and feasibility in both AIS and cardiovascular diseases. In this study, we aim to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology. The RICAS study is a prospective, randomized, blind endpoint, multicenter study. Eligible patients with ischemic stroke of anterior circulation with large artery atherosclerosis etiology, poor collateral compensation, and more than 1 month of the symptom onset, are randomly assigned into the experimental group and control group with a ratio of 1:1. The patients in experiment group will receive treatment with RIC for 1 year as an adjunct to guideline-based treatment, while patients in control group only receive guideline-based treatment. The primary outcome is proportion of collateral status improvement, which is defined as an increase of ASITN/SIR score of 1 or more assessed on DSA at 12 months after randomization. The safety outcomes include RIC-related adverse events. A maximum of 300 patients (150 participants per group) are required to test the superiority hypothesis with 80% power (using a two-sided α = 0.05) to detect the 15% difference. The primary endpoint will further be stratified by age, gender, inclusion event (acute ischemic stroke ore transient ischemic stroke), tandem lesion, history of hypertension, hypercholesterolemia, diabetes mellitus, ischemic stroke, transient ischemic attack, and myocardial infarction. This study will provide the direct evidence for improvement of collateral status by chronic RIC treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic preconditioning and guideline-based treatment | Experimental | Device: Remote ischemic preconditioning5 cycles of cuff inflation (200mmHg for 5 minutes) and deflation (for 5 minutes), once or twice daily for 12 months. |
| Guideline-based treatment | No intervention | –Guideline-based treatment. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Age over 40 years old;
- 2. Diagnosed with ischemic stroke (including TIA and cerebral infarction), with onset time of more than 1 month;
- 3. Culprit arteries are the large arteries of the anterior circulation with atherosclerotic stenosis (≥50%) or occlusion;
- 4. ASITN/SIR collateral circulation of 0-3 based on DSA evaluation;
- 5. First onset or prior onset with no significant sequelae (mRS ≤ 2);
Key exclusion criteria (17 listed)
- 1) Patients with severe infection or serious diseases such as liver, kidney, hematopoietic system, endocrine system, etc.;
- 2) Patients with a history of stroke and severe sequelae (mRS≥3);
- 3) arterial stenosis due to aortic dissection, moyamoya disease; Any known vasculitic disease; herpes zoster, varicella-zoster or other viral infections with vascular lesions; neurosyphilis; other intracranial infections; any intracranial artery stenosis associated with hypercytosis of cerebrospinal fluid; radiation-induced vascular lesions; myofiber dysplasia; sickle cell disease; neurofibromas; benign vascular lesions of the central nervous system; postpartum vascular disease; stenosis of the intracranial arteries due to vasospasm or thrombosm;
- 4) Uncontrolled severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110 mmHg after drug treatment) ;
- 5) Subclavian artery stenosis ≥50% or subclavian artery steal syndrome;
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 preconditioningThe patients in experiment group will receive treatment with RIC (5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg) for 1 year as an adjunct to guideline-based treatment. | Device | Remote ischemic preconditioning and guideline-based treatment |
Primary outcome
The proportion of collateral status improvement.
Time frame: 12 months
collateral status improvement is defined as an increase of ASITN/SIR score of 1 or more assessed on DSA at 12 months after randomization.
6 secondary outcomes
The influence of RIC to neurological functions
Time frame: 12 months
Recurrence of nonfatal ischemic stroke in 12 months
Time frame: 12 months
Composite vascular events
Time frame: 12 months
Influence on heart function
Time frame: 12 months
Influence on kidney function
Time frame: 12 months
RIC-related adverse events
Time frame: 12 months
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 27 Apr 2026.
- Derived from this study: PubMed 39968799Zhao ZA, Lv Y, Chen HS. Effect of RICAS (Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke): Rationale and Design. J Am Heart Assoc. 2025 Mar 18;14(6):e038570. doi: 10.1161/JAHA.124.038570. Epub 2025 Feb 19.
- Individual participant dataSharing planned: Yes. Data dictionary.
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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.
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 preconditioning in people with Stroke, Ischemic, 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 7 inclusion and 17 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 27 Apr 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?
Contact Ziai Zhao (18304098115, zhaoziai@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of collateral status improvement. (time frame: 12 months). 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 NCT06170944, 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 27 Apr 2026.