NCT07531394

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 580 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-12-30
• Completion: 2028-12-01
• First posted: 2026-04-15
• Last updated: 2026-04-15