NCT02405130

The RESTORE-SIRIO Randomized Controlled Trial

Impact of intRacoronary adrEnaline on Myocardial reperfuSion in STEMI paTients With Persistent Impaired cORonary Flow After pErcutaneous Coronary Intervention: the RESTORE-SIRIO Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for treating acute ST-segment elevation myocardial infarction (STEMI). The main goals are to restore epicardial infarct-related artery patency and to achieve microvascular reperfusion as early as possible. No-reflow is the term used to describe inadequate myocardial perfusion of a given coronary segment without angiographic evidence of persistent mechanical obstruction of epicardial vessels and it refers to the high resistance of microvascular blood flow encountered during opening of the infarct-related coronary artery. Despite optimal evidence-based PPCI, myocardial no-reflow can still occur, negating many of the benefits of restoring culprit vessel patency, and is associated with a worse in-hospital and long-term prognosis. Several strategies have been tested to revert the no-reflow including the use of thrombectomy, glycoprotein IIb/IIIa inhibitors and the use of intracoronary adenosine, but none has been demonstrated to effectively counteract the phenomenon. The trial aims to show the effect of the administration of intracoronary adrenalin on myocardial reperfusion assessed by magnetic resonance in patients with STEMI undergoing PCI and with persistent coronary angiographic The Thrombolysis in Myocardial Infarction (TIMI) 0-1 flow during the interventional procedure after failure of standard therapy.

Conditions

• Percutaneous Coronary Intervention
• No-reflow Phenomen
• Acute ST-segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
OTHER	intracoronary epinephrine	after failure of standard therapy patients will treated with epinephrine
OTHER	no intracoronary epinephrine	patients will receive standard therapy only

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-04-01
• Last updated: 2016-02-11

Locations

1 site across 1 country: Germany