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

NCT07531394 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2026-04-15

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Capital Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-12-30
Completion
2028-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07531394 on ClinicalTrials.gov