Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Myocardial Injury Following Acute Ischemic Stroke

NCT07531394 | Not Yet Recruiting Phase 3

• 1 other identifier: RIMIS
• Study Type: interventional
• Target: 580
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

RIC group

EXPERIMENTAL

Device: Remote Ischemic Conditioning

Sham RIC group

SHAM COMPARATOR

Device: Sham Remote Ischemic Conditioning

Interventions

Remote Ischemic Conditioning DEVICE

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

RIC group

Sham Remote Ischemic Conditioning DEVICE

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.

Sham RIC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Capital Medical University: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04