Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Myocardial Injury Foll… (NCT07531394) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Myocardial Injury Following Acute Ischemic Stroke
580 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Pre-stroke mRS score ≥ 2;
. AIS patients receiving intravenous thrombolysis or endovascular thrombectomy;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of MACCEs within 3 months after randomization
. 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;
. 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.;
. Patients who are planning for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for the index AMI within 3 months;
. Severe liver or kidney dysfunction or malignant tumors;