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The RESTORE-SIRIO Randomized Controlled Trial

NCT02405130 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-02-11

No results posted yet for this study

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

OTHER

intracoronary epinephrine

after failure of standard therapy patients will treated with epinephrine

OTHER

no intracoronary epinephrine

patients will receive standard therapy only

Sponsors & Collaborators

  • SIRIO MEDICINE

    collaborator UNKNOWN

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Eliano P Navarese, MD, PhD, FESC · Division of Cardiology, Pulmonary Disease and Vascular Medicine, Heinrich-Heine University Dusseldorf

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02405130 on ClinicalTrials.gov