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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heinrich-Heine University, Duesseldorf

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SIRIO MEDICINE

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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