Ischemic Stroke, AcutePhase 3NCT07531394
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Myocardial Injury Following Acute Ischemic Stroke
A Phase 3 study testing Remote Ischemic Conditioning in people with Ischemic Stroke, Acute and Myocardial Injury, run by Capital Medical University.
Trial summary
Introduction: The management of acute myocardial injury following acute ischemic stroke (AMI-AIS), a frequent complication that severely worsens prognosis, is challenging. Remote ischemic conditioning (RIC) has demonstrated therapeutic potential in separate cardiac and cerebrovascular diseases, and preliminary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute, Myocardial Injury
- What is being tested?
- Remote Ischemic Conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 580 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Dec 2028
- Phase
- Phase 3
- 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, regardless of sex;
- AIS confirmed by neuroimaging within 72 hours of symptom onset (or last known well time);
- Acute myocardial injury confirmed by serial measurements of plasma cardiac troponin (cTn) within 72 hours of symptom onset [19];
- Written informed consent provided by the participant or their legal authorized representative.
Who cannot join
- Pre-stroke mRS score ≥ 2;
- AIS patients receiving intravenous thrombolysis or endovascular thrombectomy;
- Definite history of coronary heart disease, severe valvular heart disease, arrhythmia, heart failure, cardiomyopathy, elevated cTn, and abnormal electrocardiogram (ECG) before onset;
- Suspicious cardiac-related symptoms (recurrent/persistent chest pain/chest tightness/palpitations, etc.) within 14 days before the index stroke;
- Any disorder that could potentially lead to elevated pre-stroke cTn: sepsis, acute kidney injury, rhabdomyolysis, major cardiac surgery or myocardial infarction, previous ischemic or hemorrhagic stroke, congestive heart failure, pulmonary embolism, deep vein thrombosis, endocarditis, severe anemia, thyroid dysfunction, Drug application, etc.;
- Patients who are planning for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for the index AMI within 3 months;
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- Severe liver or kidney dysfunction or malignant tumors;
- Uncontrolled hypertension (systolic blood pressure ≥ 200mmHg at enrollment despite medication);
- Any limb deformity, vascular or soft tissue injury, orthopedic trauma, or other conditions affecting the implementation of RIC;
- Pregnancy or lactation period;
- Patients with psychiatric disorders or other reasons unable to cooperate with treatment and follow-up.
About this study
Introduction: The management of acute myocardial injury following acute ischemic stroke (AMI-AIS), a frequent complication that severely worsens prognosis, is challenging. Remote ischemic conditioning (RIC) has demonstrated therapeutic potential in separate cardiac and cerebrovascular diseases, and preliminary single-center evidence suggests its safety and efficacy in patients with acute ischemic stroke (AIS) complicating acute myocardial infarction. Therefore, we propose to conduct a multicenter, randomized controlled trial to definitively evaluate the safety and efficacy of RIC in patients with AMI-AIS.
Methods: This is a multicenter, randomized, double-blind, sham-controlled trial of 580 participants with AMI-AIS. Participants will be randomized to receive either the RIC procedures or sham RIC procedures twice daily for 14 consecutive days. A 3-month follow-up will be conducted to assess the safety and efficacy of RIC in AMI-AIS patients. The primary study outcome is the incidence of major adverse cardio-cerebrovascular events (MACCEs). The secondary outcomes include mortality, neurological and cardiac function, cerebral infarct volume, and cerebral perfusion.
- Conditions
- Ischemic Stroke, Acute, Myocardial Injury
- Being tested
- Remote Ischemic Conditioning, Sham 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
Participants in the RIC group will undergo twice-daily RIC procedure for 14 consecutive days. Each procedure consists of five cycles of simultaneous bilateral arm ischemia (5 minutes per cycle, with cuff pressure set to 200 mmHg for the RIC group), followed by 5 minutes of reperfusion per cycle, totaling 45 minutes per session. The RIP device (IPC-906D) is an easy-to-use, automated device developed specifically for this purpose
Sham Remote Ischemic ConditioningDevice
Participants in the sham RIC group will undergo twice-daily sham RIC procedure for 14 consecutive days. Each procedure consists of five cycles of simultaneous bilateral arm ischemia (5 minutes per cycle, with cuff pressure set to 60 mmHg for the sham RIC group), followed by 5 minutes of reperfusion per cycle, totaling 45 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | Not described Receives: Device: Remote Ischemic Conditioning |
| Sham RIC group | Sham comparator | Not described Receives: Device: Sham Remote Ischemic Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of MACCEs within 3 months after randomization
The incidence of MACCEs within 3 months after randomization, defined as a composite of nonfatal acute myocardial infarction, acute coronary syndrome (excluding acute myocardial infarction), nonfatal stroke, transient ischemic attack (TIA), nonfatal acute decompensated heart failure, and cardiovascular death.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531394
- Sponsor's protocol ID
- RIMIS
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 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 Acute Myocardial Injury Following Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07531394
- Acronym / sponsor ID
- RIMIS
- Conditions
- Ischemic Stroke, Acute, Myocardial Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 15 Apr 2026 (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.
Introduction: The management of acute myocardial injury following acute ischemic stroke (AMI-AIS), a frequent complication that severely worsens prognosis, is challenging. Remote ischemic conditioning (RIC) has demonstrated therapeutic potential in separate cardiac and cerebrovascular diseases, and preliminary single-center evidence suggests its safety and efficacy in patients with acute ischemic stroke (AIS) complicating acute myocardial infarction. Therefore, we propose to conduct a multicenter, randomized controlled trial to definitively evaluate the safety and efficacy of RIC in patients with AMI-AIS.
Methods: This is a multicenter, randomized, double-blind, sham-controlled trial of 580 participants with AMI-AIS. Participants will be randomized to receive either the RIC procedures or sham RIC procedures twice daily for 14 consecutive days. A 3-month follow-up will be conducted to assess the safety and efficacy of RIC in AMI-AIS patients. The primary study outcome is the incidence of major adverse cardio-cerebrovascular events (MACCEs). The secondary outcomes include mortality, neurological and cardiac function, cerebral infarct volume, and cerebral perfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: Remote Ischemic Conditioning |
| Sham RIC group | Sham comparator | Device: Sham Remote Ischemic Conditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years, regardless of sex;
- AIS confirmed by neuroimaging within 72 hours of symptom onset (or last known well time);
- Acute myocardial injury confirmed by serial measurements of plasma cardiac troponin (cTn) within 72 hours of symptom onset [19];
- Written informed consent provided by the participant or their legal authorized representative.
Key exclusion criteria (11 listed)
- Pre-stroke mRS score ≥ 2;
- AIS patients receiving intravenous thrombolysis or endovascular thrombectomy;
- Definite history of coronary heart disease, severe valvular heart disease, arrhythmia, heart failure, cardiomyopathy, elevated cTn, and abnormal electrocardiogram (ECG) before onset;
- Suspicious cardiac-related symptoms (recurrent/persistent chest pain/chest tightness/palpitations, etc.) within 14 days before the index stroke;
- Any disorder that could potentially lead to elevated pre-stroke cTn: sepsis, acute kidney injury, rhabdomyolysis, major cardiac surgery or myocardial infarction, previous ischemic or hemorrhagic stroke, congestive heart failure, pulmonary embolism, deep vein thrombosis, endocarditis, severe anemia, thyroid dysfunction, Drug application, etc.;
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 ConditioningParticipants in the RIC group will undergo twice-daily RIC procedure for 14 consecutive days. Each procedure consists of five cycles of simultaneous bilateral arm ischemia (5 minutes per cycle, with cuff pressure set to 200 mmHg for the RIC group), followed by 5 minutes of reperfusion per cycle, totaling 45 minutes per session. The RIP device (IPC-906D) is an easy-to-use, automated device developed specifically for this purpose | Device | RIC group |
| Sham Remote Ischemic ConditioningParticipants in the sham RIC group will undergo twice-daily sham RIC procedure for 14 consecutive days. Each procedure consists of five cycles of simultaneous bilateral arm ischemia (5 minutes per cycle, with cuff pressure set to 60 mmHg for the sham RIC group), followed by 5 minutes of reperfusion per cycle, totaling 45 minutes per session. | Device | Sham RIC group |
Primary outcome
The incidence of MACCEs within 3 months after randomization
Time frame: 3 months
The incidence of MACCEs within 3 months after randomization, defined as a composite of nonfatal acute myocardial infarction, acute coronary syndrome (excluding acute myocardial infarction), nonfatal stroke, transient ischemic attack (TIA), nonfatal acute decompensated heart failure, and cardiovascular death.
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 15 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remote Ischemic Conditioning in people with Ischemic Stroke, Acute and Myocardial Injury, run by Capital Medical University.
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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
The incidence of MACCEs within 3 months after randomization (time frame: 3 months). 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 15 Apr 2026.