The RESTORE-SIRIO Randomized Controlled Trial

Not Applicable

Withdrawn

• Conditions: Percutaneous Coronary Intervention; No-reflow Phenomen; Acute ST-segment Elevation Myocardial Infarction
• Interventions: Other: intracoronary epinephrine; Other: no intracoronary epinephrine

• Registration Number: NCT02405130
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-27
• Study Start: 2015-04
• Study First Posted: 2015-04-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• ≥18 years of age
• 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

• evident clinical arrhythmias (ventricular tachycardia/ventricular fibrillation)
• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
epinephrine	intracoronary 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
no intracoronary epinephrine	no intracoronary epinephrine	no epinephrine

Primary Outcome Measures

Name	Time	Method
myocardial infarct size (% total LV mass)	48-72 hours post intervention	cMRI parameters: myocardial infarct size (% total LV mass)

Secondary Outcome Measures

Name	Time	Method
Incidence and extent of microvascular obstruction	48-72 hours and 30 days post intervention	cMRI parameter
Myocardial salvage index (MSI)	48-72 hours and 30 days post intervention	cMRI parameter
Intra-myocardial haemorrhage (IMH)	48-72 hours and 30 days post intervention	cMRI parameter
LV ejection fraction (LVEF) and volumes	48-72 hours and 30 days post intervention	cMRI parameter
Thrombolysis in Myocardial Infarction (TIMI) flow grade)	48-72 hours post intervention	Angiographic markers
Myocardial blush grade (MBG)	48-72 hours post intervention	Angiographic markers
Computer-assisted myocardial blush quantification using the software 'Quantitative Blush Evaluator' (QuBE)	48-72 hours post intervention	Angiographic markers
Degree of ST segment resolution on ECG	48-72 hours post intervention

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Düsseldorf, Germany