Percutaneous Coronary InterventionRESTORE-SIRIONCT02405130
The RESTORE-SIRIO Randomized Controlled Trial
A study testing intracoronary epinephrine and no intracoronary epinephrine in people with Percutaneous Coronary Intervention and No-reflow Phenomen, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, No-reflow Phenomen, Acute ST-segment Elevation Myocardial Infarction
- What is being tested?
- intracoronary epinephrine and no intracoronary epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
Official title: 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.
- Conditions
- Percutaneous Coronary Intervention, No-reflow Phenomen, Acute ST-segment Elevation Myocardial Infarction
- Being tested
- intracoronary epinephrine, no intracoronary epinephrine
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracoronary epinephrineOther
after failure of standard therapy patients will treated with epinephrine
no intracoronary epinephrineOther
patients will receive standard therapy only
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: intracoronary epinephrine |
| no intracoronary epinephrine | Other | no epinephrine Receives: Other: no intracoronary epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial infarct size (% total LV mass)
cMRI parameters: myocardial infarct size (% total LV mass)
Measured: 48-72 hours post intervention
Secondary outcomes (8)
Incidence and extent of microvascular obstruction
cMRI parameter
Measured: 48-72 hours and 30 days post intervention
Myocardial salvage index (MSI)
cMRI parameter
Measured: 48-72 hours and 30 days post intervention
Intra-myocardial haemorrhage (IMH)
cMRI parameter
Measured: 48-72 hours and 30 days post intervention
LV ejection fraction (LVEF) and volumes
cMRI parameter
Measured: 48-72 hours and 30 days post intervention
Thrombolysis in Myocardial Infarction (TIMI) flow grade)
Angiographic markers
Measured: 48-72 hours post intervention
Myocardial blush grade (MBG)
Angiographic markers
Measured: 48-72 hours post intervention
Computer-assisted myocardial blush quantification using the software 'Quantitative Blush Evaluator' (QuBE)
Angiographic markers
Measured: 48-72 hours post intervention
Degree of ST segment resolution on ECG
Measured: 48-72 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- SIRIO MEDICINE
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Eliano P Navarese, MD, PhD, FESC, Study director, Division of Cardiology, Pulmonary Disease and Vascular Medicine, Heinrich-Heine University Dusseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405130
- Sponsor's protocol ID
- RESTORE-SIRIO
- Acronym
- RESTORE-SIRIO
- Status last verified
- Feb 2016
- First submitted
- 24 Mar 2015
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02405130
- Acronym / sponsor ID
- RESTORE-SIRIO / RESTORE-SIRIO
- Conditions
- Percutaneous Coronary Intervention, No-reflow Phenomen, Acute ST-segment Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- SIRIO MEDICINE
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epinephrine | Active comparator | Other: intracoronary epinephrineintracoronary 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 | Other | Other: no intracoronary epinephrineno epinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (8 listed)
- evident clinical arrhythmias (ventricular tachycardia/ventricular fibrillation)
- evidence of coronary dissection or spasm
- Parkinson symptoms
- closed angle glaucoma
- thyroid disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intracoronary epinephrineafter failure of standard therapy patients will treated with epinephrine | Other | epinephrine |
| no intracoronary epinephrinepatients will receive standard therapy only | Other | no intracoronary epinephrine |
Primary outcome
myocardial infarct size (% total LV mass)
Time frame: 48-72 hours post intervention
cMRI parameters: myocardial infarct size (% total LV mass)
8 secondary outcomes
Incidence and extent of microvascular obstruction
Time frame: 48-72 hours and 30 days post intervention
Myocardial salvage index (MSI)
Time frame: 48-72 hours and 30 days post intervention
Intra-myocardial haemorrhage (IMH)
Time frame: 48-72 hours and 30 days post intervention
LV ejection fraction (LVEF) and volumes
Time frame: 48-72 hours and 30 days post intervention
Thrombolysis in Myocardial Infarction (TIMI) flow grade)
Time frame: 48-72 hours post intervention
Myocardial blush grade (MBG)
Time frame: 48-72 hours post intervention
Computer-assisted myocardial blush quantification using the software 'Quantitative Blush Evaluator' (QuBE)
Time frame: 48-72 hours post intervention
Degree of ST segment resolution on ECG
Time frame: 48-72 hours post intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliano P Navarese, MD, PhD, FESC study director
Division of Cardiology, Pulmonary Disease and Vascular Medicine, Heinrich-Heine University Dusseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intracoronary epinephrine and no intracoronary epinephrine in people with Percutaneous Coronary Intervention and No-reflow Phenomen, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial infarct size (% total LV mass) (time frame: 48-72 hours post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2016.