NCT02164695

Remote Ischemic Perconditioning in Patients With ST-segment Elevation Myocardial Infarction

Cardioprotective Effects of Remote Ischemic Perconditioning in Patients With ST-segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

To evaluate whether remote ischemic per-conditioning (RIPC) can reduce infarct size in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention (PPCI) within 12 hours of symptoms onset. * Control group: PPCI only * Study group: PPCI + RIPC Primary endpoint: Infarct size measured by contrast-enhanced cardiac magnetic resonance (CMR) at 6 months after the index procedure

Detailed description

ST-elevation myocardial infarction (STEMI) is a leading cause of mortality and morbidity. Early myocardial reperfusion with either of thrombolytic therapy or primary percutaneous coronary intervention (PPCI) is the most effective strategy for reducing the size of a myocardial infarct and improving the clinical outcome. Although this process can restore blood flow to the ischemic myocardium, it can induce injury. This phenomenon termed myocardial reperfusion injury can paradoxically reduce the beneficial effects of myocardial reperfusion. The pre-clinical study in animal models of acute myocardial infarction suggests that lethal reperfusion injury accounts for up to 50% of the final size of a myocardial infarct. Remote ischemic conditioning uses brief ischemia and reperfusion of a distant organ to protect the myocardium. In animal study, remote ischemic postconditioning seems to be more effective than local postconditioning in experimental myocardial infarction.Bøtker et al. has reported remote ischemic preconditioning before hospital admission increase myocardial salvage in patients with acute myocardial infarction. The objective of this study is to evaluate whether remote ischemic per-conditioning (RIPC) can reduce late infarct size in patients with STEMI treated with PPCI within 12 hours of symptoms onset. To test this hypothesis, we will randomize patients into PPCI + RIPC or PPCI alone. We will evaluate marker of reperfusion injury using contrast cardiac magnetic resonance image.

Conditions

• ST-segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	PPCI plus RIPC	All patients will be prepared with an upper-arm blood pressure cuff before arterial puncture (contralateral in case of radial access). In patients allocated into PPCI plus RIPC group, the protocol will be started immediately after cuff preparation. Upper-arm will be exposed to 4 cycles of ischemia/reperfusion, each obtained by 5 min cuff inflation at 200mmHg, followed by 5 min complete deflation.
PROCEDURE	PPCI only	All patients randomized to PPCI only arm, the blood pressure cuff will be applied to the arm or the calf but will not be inflated.

Timeline

• Start date: 2015-01-31
• Primary completion: 2017-07-31
• Completion: 2018-01-31
• First posted: 2014-06-16
• Last updated: 2021-11-24

Locations

1 site across 1 country: South Korea