The RESTORE-SIRIO Randomized Controlled Trial

Percutaneous Coronary Intervention Clinical Trial

— RESTORE-SIRIO  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02405130
• Other study ID #: RESTORE-SIRIO
• Status: Withdrawn
• Phase: N/A
• First received: March 24, 2015
• Last updated: February 10, 2016
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2016
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

Other:
• intracoronary epinephrine
after failure of standard therapy patients will treated with epinephrine
• no intracoronary epinephrine
patients will receive standard therapy only

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	SIRIO MEDICINE

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	creatine kinase and troponin I release		48-72 hours post intervention	No
Other	major cardiovascular events (MACE)	death, need for Target Lesion Revascularization, recurrent myocardial infarction (MI), new or worsening heart failure	30 days post intervention	Yes
Primary	myocardial infarct size (% total LV mass)	cMRI parameters: myocardial infarct size (% total LV mass)	48-72 hours post intervention	No
Secondary	Incidence and extent of microvascular obstruction	cMRI parameter	48-72 hours and 30 days post intervention	No
Secondary	Myocardial salvage index (MSI)	cMRI parameter	48-72 hours and 30 days post intervention	No
Secondary	Intra-myocardial haemorrhage (IMH)	cMRI parameter	48-72 hours and 30 days post intervention	No
Secondary	LV ejection fraction (LVEF) and volumes	cMRI parameter	48-72 hours and 30 days post intervention	No
Secondary	Thrombolysis in Myocardial Infarction (TIMI) flow grade)	Angiographic markers	48-72 hours post intervention	No
Secondary	Myocardial blush grade (MBG)	Angiographic markers	48-72 hours post intervention	No
Secondary	Computer-assisted myocardial blush quantification using the software 'Quantitative Blush Evaluator' (QuBE)	Angiographic markers	48-72 hours post intervention	No
Secondary	Degree of ST segment resolution on ECG		48-72 hours post intervention	No

External Links

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