Ischemic StrokeRIC-ENDNCT07237542
Effect of Remote Ischemic Preconditioning on Early Neurological Deterioration in Acute Perforating Artery Infarction
A study testing remote ischemic preconditioning in people with Ischemic Stroke and Remote Ischaemic Preconditioning, run by Jinling Hospital, China at 1 site in China.
Trial summary
This study aims to conduct a prospective, randomized, double-blind, multicenter, parallel-controlled, group-sequential trialto scientifically evaluate the safety and efficacy of remote ischemic preconditioning (RIC) in preventing early neurological deterioration (END) in patients with acute perforating artery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Remote Ischaemic Preconditioning
- What is being tested?
- remote ischemic preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 910 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2025to 20 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- Diagnosed with acute ischemic stroke;
- Clinical symptoms consistent with perforating artery infarction (NIHSS score ≤5, with consciousness item 1a ≤1);
- Time from onset to randomization within 48 hours;
- Diffusion-weighted imaging (DWI) showing a single infarct in the perforating artery territory with a maximum diameter ≤30 mm, meeting at least one of the following:
- Diameter ≤15 mm and involving two or more axial slices; (2) Maximum diameter ≥15 mm; (3) Connected to the ventral surface of the pons but not crossing the midline; 6) Stenosis of parent artery <70%; 7) Signed informed consent obtained from the patient or their legally authorized representative.
Who cannot join
- Received intravenous thrombolysis or endovascular treatment prior to randomization;
- Secondary stroke caused by brain tumor, traumatic brain injury, hematologic disorders, or other conditions;
- History of intracranial hemorrhage;
- Presence of RIC contraindications, such as severe upper limb soft tissue injury, fracture, subclavian artery stenosis, or peripheral vascular disease;
- Uncontrolled severe hypertension (systolic blood pressure [BP] ≥180 mmHg or diastolic BP ≥110 mmHg);
- Severe hepatic or renal dysfunction (Alanine Aminotransferase or Aspartate Aminotransferase > 3 × upper limit of normal; creatine kinase >3 × upper limit of normal; estimated Glomerular Filtration Rate < 30 mL / min / 1.73 m²);
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- Patients with thrombocytopenic purpura, coagulation disorders, or active visceral bleeding;
- Patients in the acute phase of fundus hemorrhage;
- History of severe aphasia or psychiatric disorders affecting clinical assessment;
- Life expectancy <90 days;
- Pregnancy;
- Inability to comply with follow-up;
- Participation in other clinical trials.
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
Jinling Hospital, Medical School of Nanjing University, Nanjing
Nanjing, Jiangsu, 210002
Wusheng Zhu, PhD, +86 2584801861, wusheng.zhu@nju.edu.cn
Rui Liu, PhD
About this study
Official title: Effect of Remote Ischemic Preconditioning on Early Neurological Deterioration in Acute Perforating Artery Infarction (RIC-END): A Randomised Multicentre Trial
This study aims to conduct a prospective, randomized, double-blind, multicenter, parallel-controlled, group-sequential trialto scientifically evaluate the safety and efficacy of remote ischemic preconditioning (RIC) in preventing early neurological deterioration (END) in patients with acute perforating artery infarction (PAI).
Read the detailed description
Penetrating artery infarction (PAI) is a single small deep infarct within the territory of a perforating artery, accounting for 15.3%-25% of all ischemic strokes. Early neurological deterioration (END) is a critical factor contributing to poor prognosis in PAI. END is generally defined as an increase of ≥2 points on the National Institutes of Health Stroke Scale (NIHSS) within 7 days after stroke onset. Remote ischemic preconditioning (RIC) involves repeated, low-intensity ischemic training of both upper limbs to enhance the resistance of organs to severe ischemic injury. RIC confers protective effects on ischemic brain tissue and may serve as a new therapeutic approach for intracranial atherosclerosis and acute cerebral infarction. However, large-scale randomized controlled trials evaluating the clinical efficacy of RIC in acute PAI are lacking. Therefore, this study aims to conduct a multicenter, prospective, randomized clinical trial to scientifically assess the clinical efficacy of RIC in patients with acute PAI, providing evidence-based support for its application in this population.
In this trial, patients with acute PAI (within 48 hours from onset to randomization) will be included. In the screening stage, participants who meet the trial's inclusion criteria-after completing screening/baseline assessment and signing the informed consent-will be randomly assigned in a 1:1 ratio to one of the following two treatment groups: the experimental group will receive RIC (200 mmHg), and the control group will receive sham RIC (60 mmHg). The primary end point is the incidence of END within 5 days after randomization.
- Conditions
- Ischemic Stroke, Remote Ischaemic Preconditioning
- Being tested
- remote ischemic preconditioning, sham remote ischemic preconditioning
- Keywords
- perforating artery stroke, remote ischemic preconditioning, early neurological deterioration, randomized controlled trial
- 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 standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 200 mmHg.
sham remote ischemic preconditioningDevice
The standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 60 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | The standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 200 mmHg. Receives: Device: remote ischemic preconditioning |
| shame RIC group | Sham comparator | The standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 60 mmHg. Receives: Device: sham remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of early neurological deterioration
an increase of ≥2 points in the National Institutes of Health Stroke Scale (NIHSS), including an increase of ≥1 point in the motor score. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Measured: 5 days after randomization
Secondary outcomes (7)
The incidence of early neurological deterioration
an increase of ≥2 points in the National Institutes of Health Stroke Scale (NIHSS), including an increase of ≥1 point in the motor score. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Measured: 2 days after randomization
Proportion of patients with a modified Rankin Scale score of 0-1
modified Ranking score: ranging from 0 to 6, with higher values indicating a worse functional outcome.
Measured: 90 days after randomization
The incidence of early neurological improvement
defined as a decrease of ≥2 points in National Institutes of Health Stroke Scale (NIHSSS). NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Measured: 5 days after randomization
The incidence of early neurological improvement
defined as a decrease of ≥2 points in National Institutes of Health Stroke Scale (NIHSS). NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Measured: 2 days after randomization
The incidence of major adverse cardiovascular events
Major adverse cardiovascular events (MACE) refers to a composite measure of serious cardiovascular complications, typically including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, sometimes also encompassing hospitalization for unstable angina or urgent revascularization.
Measured: 90 days after randomization
Barthel Index
Barthel Index is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)
Measured: 90 days after randomization
EuroQol 5-Dimension 5-Level Questionnaire score
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L score) is a standardized index measuring a person's overall health-related quality of life, based on five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five levels of severity. EQ-5D-5L scores range from -0.59 to 1, where 1 is the best possible health state.
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start11 Dec 2025
- Primary completion20 Nov 2027 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 910 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinfeng Liu, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237542
- Sponsor's protocol ID
- RIC-END
- Acronym
- RIC-END
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 3 Feb 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Preconditioning on Early Neurological Deterioration in Acute Perforating Artery Infarction (RIC-END): A Randomised Multicentre Trial
- ClinicalTrials.gov ID
- NCT07237542
- Acronym / sponsor ID
- RIC-END / RIC-END
- Conditions
- Ischemic Stroke, Remote Ischaemic Preconditioning
- Keywords
- perforating artery stroke, remote ischemic preconditioning, early neurological deterioration, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 910 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 20 Nov 2027 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 20 Nov 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.
This study aims to conduct a prospective, randomized, double-blind, multicenter, parallel-controlled, group-sequential trialto scientifically evaluate the safety and efficacy of remote ischemic preconditioning (RIC) in preventing early neurological deterioration (END) in patients with acute perforating artery infarction (PAI).
Detailed description
Penetrating artery infarction (PAI) is a single small deep infarct within the territory of a perforating artery, accounting for 15.3%-25% of all ischemic strokes. Early neurological deterioration (END) is a critical factor contributing to poor prognosis in PAI. END is generally defined as an increase of ≥2 points on the National Institutes of Health Stroke Scale (NIHSS) within 7 days after stroke onset. Remote ischemic preconditioning (RIC) involves repeated, low-intensity ischemic training of both upper limbs to enhance the resistance of organs to severe ischemic injury. RIC confers protective effects on ischemic brain tissue and may serve as a new therapeutic approach for intracranial atherosclerosis and acute cerebral infarction. However, large-scale randomized controlled trials evaluating the clinical efficacy of RIC in acute PAI are lacking. Therefore, this study aims to conduct a multicenter, prospective, randomized clinical trial to scientifically assess the clinical efficacy of RIC in patients with acute PAI, providing evidence-based support for its application in this population.
In this trial, patients with acute PAI (within 48 hours from onset to randomization) will be included. In the screening stage, participants who meet the trial's inclusion criteria-after completing screening/baseline assessment and signing the informed consent-will be randomly assigned in a 1:1 ratio to one of the following two treatment groups: the experimental group will receive RIC (200 mmHg), and the control group will receive sham RIC (60 mmHg). The primary end point is the incidence of END within 5 days after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: remote ischemic preconditioningThe standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 200 mmHg. |
| shame RIC group | Sham comparator | Device: sham remote ischemic preconditioningThe standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 60 mmHg. |
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 or older;
- Diagnosed with acute ischemic stroke;
- Clinical symptoms consistent with perforating artery infarction (NIHSS score ≤5, with consciousness item 1a ≤1);
- Time from onset to randomization within 48 hours;
- Diffusion-weighted imaging (DWI) showing a single infarct in the perforating artery territory with a maximum diameter ≤30 mm, meeting at least one of the following:
Key exclusion criteria (13 listed)
- Received intravenous thrombolysis or endovascular treatment prior to randomization;
- Secondary stroke caused by brain tumor, traumatic brain injury, hematologic disorders, or other conditions;
- History of intracranial hemorrhage;
- Presence of RIC contraindications, such as severe upper limb soft tissue injury, fracture, subclavian artery stenosis, or peripheral vascular disease;
- Uncontrolled severe hypertension (systolic blood pressure [BP] ≥180 mmHg or diastolic BP ≥110 mmHg);
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 standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 200 mmHg. | Device | RIC group |
| sham remote ischemic preconditioningThe standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 60 mmHg. | Device | shame RIC group |
Primary outcome
The incidence of early neurological deterioration
Time frame: 5 days after randomization
an increase of ≥2 points in the National Institutes of Health Stroke Scale (NIHSS), including an increase of ≥1 point in the motor score. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
7 secondary outcomes
The incidence of early neurological deterioration
Time frame: 2 days after randomization
Proportion of patients with a modified Rankin Scale score of 0-1
Time frame: 90 days after randomization
The incidence of early neurological improvement
Time frame: 5 days after randomization
The incidence of early neurological improvement
Time frame: 2 days after randomization
The incidence of major adverse cardiovascular events
Time frame: 90 days after randomization
Barthel Index
Time frame: 90 days after randomization
EuroQol 5-Dimension 5-Level Questionnaire score
Time frame: 90 days after randomization
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 3 Feb 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.
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 Ischemic Stroke and Remote Ischaemic Preconditioning, run by Jinling Hospital, 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 13 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 3 Feb 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. Some participants in this study may receive a placebo. 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 Wusheng Zhu, PhD (+86 2584801861, wusheng.zhu@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of early neurological deterioration (time frame: 5 days after randomization). 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 3 Feb 2026.