Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
352 participants
OBSERVATIONAL
2013-09-30
2019-04-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* The patient must have symptoms consistent with AMI
* MI with ST-segment elevation
* The patient is eligible for PCI.
* The expected timing of the treatment pathway for the patient will allow for at least 10 minutes of cooling with the IVTM System prior to PCI.
* The patient or patient legal representative is willing to provide written, informed consent to participate in this clinical study.
Exclusion Criteria
* The patient is experiencing cardiogenic shock
* The patient is experiencing acute pulmonary edema.
* The patient is presenting with cardiac arrest.
* The patient is presenting with Killip risk stratification class II through IV.
* The patient is presenting with Atrial Fibrillation.
* The patient has a history of a prior large myocardial infarct or an infarct in the same segment that is currently affected.
* The patient requires an immediate surgical or procedural intervention other than PCI
* The patient has an aortic dissection.
* The patient has hepatic failure.
* The patient has end stage kidney disease.
* The patient is febrile
* Known chronic Congestive Heart Failure (CHF).
* Known previous CABG.
* Known recent stroke
* Cardio-pulmonary decompensation that has occurred en route to the hospital
* Contraindications to hypothermia
* The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
* The patient has a known history of coagulopathy
* The patient is known to be pregnant
* The patient has a known hypersensitivity to antishivering medications.
* Patient has a known history of severe hepatic or renal impairment.
* The patient has an Inferior Vena Cava filter in place (IVC).
* The patient has a life expectancy of less than 1 year
* The patient has a known, unresolved history of drug use
* The patient is currently enrolled another investigational drug or device trial
18 Years
ALL
No
Sponsors
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ZOLL Circulation, Inc., USA
INDUSTRY
Responsible Party
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Locations
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University Hospital Brno, Internal and Cardiology Department
Brno, , Czechia
North Estonia Medical Center
Tallinn, , Estonia
Ruppiner Kliniken GmbH
Neuruppin, , Germany
Heart Center Balatonfüred
Balatonfüred, , Hungary
Gottsegen Hungarian Institute of Cardiology
Budapest, , Hungary
Semmelweis University Heart and Vascular Center
Budapest, , Hungary
Medical Centre Hungarian Defence Forces
Budapest, , Hungary
Medical and Health Science Center University of Debrecen
Debrecen, , Hungary
University of Miskolc Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital
Miskolc, , Hungary
Heart Institute University of Pecs
Pécs, , Hungary
Szent-Györgyi Albert Clinical Centre, II (University of Szeged)
Szeged, , Hungary
Vilnius University Hospital (Santariskiu Klinikos, Santariskiu)
Vilnius, , Lithuania
Nicolaus Copernicus University, Collegium Medicum University Hospital
Bydgoszcz, , Poland
Medical University in Łódź, Bieganski Hospital
Lodz, , Poland
Institute of Cardiology,
Warsaw, , Poland
Silesian Center for Heart Diseases, Zabrze
Zabrze, , Poland
Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)
Belgrade, , Serbia
Institute of Cardiovascular Diseases Vojvodina
Kamenitz, , Serbia
University Clinical Hospital Center Zemun
Zemun, , Serbia
Royal Sussex County Hospital
Brighton, , United Kingdom
The London Barts Department of Cardiology
London, , United Kingdom
Cardiac Research Sister, King's College Hospital
London, , United Kingdom
Manchester Heart Centre Manchester Royal InfirmaryCentral Manchester University Hospitals NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Other Identifiers
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EDC-2191
Identifier Type: -
Identifier Source: org_study_id