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.
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.
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;
Parallel
Remote Ischemic Conditioning
DeviceParticipants 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 Conditioning
DeviceParticipants 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.
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.
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