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

April 9, 2026 updated by: Ji Xunming,MD,PhD, Capital Medical University

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

580

Phase

  • Phase 3

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years, regardless of sex;
  2. AIS confirmed by neuroimaging within 72 hours of symptom onset (or last known well time);
  3. Acute myocardial injury confirmed by serial measurements of plasma cardiac troponin (cTn) within 72 hours of symptom onset [19];
  4. Written informed consent provided by the participant or their legal authorized representative.

Exclusion Criteria:

  1. Pre-stroke mRS score ≥ 2;
  2. AIS patients receiving intravenous thrombolysis or endovascular thrombectomy;
  3. Definite history of coronary heart disease, severe valvular heart disease, arrhythmia, heart failure, cardiomyopathy, elevated cTn, and abnormal electrocardiogram (ECG) before onset;
  4. Suspicious cardiac-related symptoms (recurrent/persistent chest pain/chest tightness/palpitations, etc.) within 14 days before the index stroke;
  5. 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.;
  6. Patients who are planning for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for the index AMI within 3 months;
  7. Severe liver or kidney dysfunction or malignant tumors;
  8. Uncontrolled hypertension (systolic blood pressure ≥ 200mmHg at enrollment despite medication);
  9. Any limb deformity, vascular or soft tissue injury, orthopedic trauma, or other conditions affecting the implementation of RIC;
  10. Pregnancy or lactation period;
  11. Patients with psychiatric disorders or other reasons unable to cooperate with treatment and follow-up.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RIC group
Device: Remote Ischemic Conditioning
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 Comparator: Sham RIC group
Device: Sham Remote Ischemic Conditioning
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

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

Sponsor

Capital Medical University

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIMIS

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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