Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-04-30
2016-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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epinephrine
intracoronary epinephrine is two ampoules each of 1:1000 epinephrine (1 μg/mL) diluted into 100 mL of normal saline (to 20 μg/mL epinephrine solution); a 5 ml syringe prepared will then contain 100 μg
intracoronary epinephrine
after failure of standard therapy patients will treated with epinephrine
no intracoronary epinephrine
no epinephrine
no intracoronary epinephrine
patients will receive standard therapy only
Interventions
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intracoronary epinephrine
after failure of standard therapy patients will treated with epinephrine
no intracoronary epinephrine
patients will receive standard therapy only
Eligibility Criteria
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Inclusion Criteria
* presentation within 6-7 h of symptom onset of STEMI
* eligibility for reperfusion by primary-PCI
* TIMI flow grade 0-1 during the interventional procedure in the culprit vessel after the initial opening of the vessel with the coronary wire
Exclusion Criteria
* evidence of coronary dissection or spasm
* Parkinson symptoms
* closed angle glaucoma
* thyroid disorders
* known history to hypersensitivity to the drug
* pregnancy
* stage 4 or 5 CKD (eGFR \<30 mL/min/1.73 m2)
18 Years
ALL
No
Sponsors
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SIRIO MEDICINE
UNKNOWN
Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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Klinik für Kardiologie, Pneumologie und Angiologie
Klinik für Kardiologie, Pneumologie und Angiologie
Principal Investigators
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Eliano P Navarese, MD, PhD, FESC
Role: STUDY_DIRECTOR
Division of Cardiology, Pulmonary Disease and Vascular Medicine, Heinrich-Heine University Dusseldorf
Locations
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Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, , Germany
Countries
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Related Links
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Related Info
Related Info
Other Identifiers
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RESTORE-SIRIO
Identifier Type: -
Identifier Source: org_study_id
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