COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction. Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.
Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
100
Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI)
Standard of Care for PCI
Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria
North Estonia Medical Center
Tallinn, Estonia
Heart Center Balatonfüred
Balatonfüred, Hungary
Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period
Time frame: 30 day
1. Anterior Infarct Size (IS) as assessed by Cardiac Magnetic Resonance (cMR) at 4 - 6 days following the index procedure for subjects in Test and Control Arms
Time frame: 4 - 6 days
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Medical and Health Science Center University of Debrecen
Debrecen, Hungary
Heart Institute University of Pecs
Pécs, Hungary
Medical University in Łódź, Bieganski Hospital
Lodz, Poland
National Institute of Cardiology, Department of Interventional Cardiology & Angiology
Warsaw, Poland
Silesian Center for Heart Diseases
Zabrze, Poland
Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)
Belgrade, Serbia
University Clinical Hospital Center Zemun
Zemun, Serbia
...and 3 more locations