Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke (RICAS)

April 22, 2026 updated by: Hui-Sheng Chen, General Hospital of Shenyang Military Region

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shenyang, China, 110840
        • Recruiting
        • General Hospital of Northern Theater Command
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Remote ischemic preconditioning and guideline-based treatment
5 cycles of cuff inflation (200mmHg for 5 minutes) and deflation (for 5 minutes), once or twice daily for 12 months.
Device: Remote ischemic preconditioning
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.
No Intervention: Guideline-based treatment
Guideline-based treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The influence of RIC to neurological functions
Time Frame: 12 months
Neurological functions was determined by modified Rankin Scale score (0-42, higher scores mean a worse outcome )
12 months
Recurrence of nonfatal ischemic stroke in 12 months
Time Frame: 12 months
Ischemic stroke is diagnosed based on clinical symptom and neuroimaging
12 months
Composite vascular events
Time Frame: 12 months
Composite vascular events include stroke, myocardial infarction, vascular death
12 months
Influence on heart function
Time Frame: 12 months
heart function is assessed by cardiac ultrasound, electrocardiogram, myocardial enzyme profile, etc
12 months
Influence on kidney function
Time Frame: 12 months
kidney function is assessed by glomeruar filtration rate
12 months
RIC-related adverse events
Time Frame: 12 months
include local pain, intolerance, etc.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
General Hospital of Shenyang Military Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Y(2023)169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data dictionary.

IPD Sharing Time Frame

With publication.

IPD Sharing Access Criteria

Researchers whose proposed use of the data has been approved.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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