The RESTORE-SIRIO Randomized Controlled Trial (RESTORE-SIRIO)

February 10, 2016 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Other: intracoronary epinephrine
after failure of standard therapy patients will treated with epinephrine
Other: no intracoronary epinephrine
no epinephrine
Other: no intracoronary epinephrine
patients will receive standard therapy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial infarct size (% total LV mass)
Time Frame: 48-72 hours post intervention
cMRI parameters: myocardial infarct size (% total LV mass)
48-72 hours post intervention

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
creatine kinase and troponin I release
Time Frame: 48-72 hours post intervention
48-72 hours post intervention
major cardiovascular events (MACE)
Time Frame: 30 days post intervention
death, need for Target Lesion Revascularization, recurrent myocardial infarction (MI), new or worsening heart failure
30 days post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

SIRIO MEDICINE

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Estimate)

February 11, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESTORE-SIRIO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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