The RESTORE-SIRIO Randomized Controlled Trial

NCT02405130 | Withdrawn

• 1 other identifier: RESTORE-SIRIO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• myocardial infarct size (% total LV mass)

  cMRI parameters: myocardial infarct size (% total LV mass)

  48-72 hours post intervention

Secondary Outcomes (8)

• Incidence and extent of microvascular obstruction

  48-72 hours and 30 days post intervention

• Myocardial salvage index (MSI)

  48-72 hours and 30 days post intervention

• Intra-myocardial haemorrhage (IMH)

  48-72 hours and 30 days post intervention

• LV ejection fraction (LVEF) and volumes

  48-72 hours and 30 days post intervention

• Thrombolysis in Myocardial Infarction (TIMI) flow grade)

  48-72 hours post intervention

Other Outcomes (2)

• creatine kinase and troponin I release

  48-72 hours post intervention

• major cardiovascular events (MACE)

  30 days post intervention

Study Arms (2)

epinephrine

ACTIVE COMPARATOR

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

Other: intracoronary epinephrine

no intracoronary epinephrine

OTHER

no epinephrine

Other: no intracoronary epinephrine

Interventions

intracoronary epinephrine OTHER

after failure of standard therapy patients will treated with epinephrine

epinephrine

no intracoronary epinephrine OTHER

patients will receive standard therapy only

no intracoronary epinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• SIRIO MEDICINE: collaborator

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Eliano P Navarese, MD, PhD, FESC

  Division of Cardiology, Pulmonary Disease and Vascular Medicine, Heinrich-Heine University Dusseldorf

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Klinik für Kardiologie, Pneumologie und Angiologie

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 1, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 11, 2016

Record last verified: 2016-02

Locations

DE (1)