About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Remote Ischemic Conditioning
- Sham Remote Ischemic Conditioning