Clinical trial NCT02405130: The RESTORE-SIRIO Randomized Controlled Trial
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Percutaneous Coronary Intervention
No-reflow Phenomen
Acute ST-segment Elevation Myocardial Infarction
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: SIRIO MEDICINE
First posted: 2015-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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)

Primary outcomes:
measure: myocardial infarct size (% total LV mass)
timeFrame: 48-72 hours post intervention
Secondary outcomes:
measure: Incidence and extent of microvascular obstruction
timeFrame: 48-72 hours and 30 days post intervention
measure: Myocardial salvage index (MSI)
timeFrame: 48-72 hours and 30 days post intervention
measure: Intra-myocardial haemorrhage (IMH)
timeFrame: 48-72 hours and 30 days post intervention
measure: LV ejection fraction (LVEF) and volumes
timeFrame: 48-72 hours and 30 days post intervention
measure: Thrombolysis in Myocardial Infarction (TIMI) flow grade)
timeFrame: 48-72 hours post intervention
measure: Myocardial blush grade (MBG)
timeFrame: 48-72 hours post intervention
measure: Computer-assisted myocardial blush quantification using the software 'Quantitative Blush Evaluator' (QuBE)
timeFrame: 48-72 hours post intervention
measure: Degree of ST segment resolution on ECG
timeFrame: 48-72 hours post intervention
Other outcomes:
measure: creatine kinase and troponin I release
timeFrame: 48-72 hours post intervention
measure: major cardiovascular events (MACE)
timeFrame: 30 days post intervention
Locations:
city: Düsseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine, Heinrich-Heine University Dusseldorf
name: Eliano P Navarese, MD, PhD, FESC
role: STUDY_DIRECTOR
References: