COOL-AMI EU Case Series Clinical Study (COOL-AMI EU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02070913
Recruitment Status : Recruiting
First Posted : February 25, 2014
Last Update Posted : May 24, 2017
Information provided by (Responsible Party):
ZOLL Circulation, Inc., USA

Brief Summary:
A single-center, prospective case series clinical study consecutively enrolling up to 10 patients with expected duration of 12 months or less. The study objectives are to evaluate retention and the feasibility of integrating therapeutic hypothermia using the ZOLL IVTM System.

Condition or disease
Acute Myocardial Infarction

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Single-Center Case Series Clinical Study to Assess the Feasibility of Integrating Therapeutic Hypothermia Using the ZOLL IVTM System as an Adjunctive Therapy to Percutaneous Coronary Intervention in Patients With AMI
Study Start Date : September 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Primary Outcome Measures :
  1. Time from hospital arrival to Percutaneous Coronary Intervention (PCI). [ Time Frame: 24 hours ]
  2. Time from hospital arrival to initiation of cooling. [ Time Frame: 24 hours ]
  3. Proportion of subjects achieving target temperature. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Proportion of those enrolled that complete the study protocol. [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who present with clinical signs and symptoms of acute myocardial infarction and meet all Inclusion and Exclusion criteria will be considered for case study presentation in this clinical trial without regard to age, gender or ethnicity.

Inclusion Criteria:

  • The patient is 18 years of age.
  • 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 has had a previous myocardial infarction
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02070913

Contact: Renée Kochevar
Contact: Tracy Roberts 408 419 2968

University Hospital Brno, Internal and Cardiology Department Recruiting
Brno, Czechia, 625 00
Contact: Petr Kala, MDPhD    +420532232205   
Contact: Roman Millkik, MD    +420532232205   
Principal Investigator: Petr Kala, MDPhD         
North Estonia Medical Center Recruiting
Tallinn, Estonia, 13419
Contact: Peep Laanmets    + 372 617 1199   
Contact: Jaanus Laanoja   
Principal Investigator: Peep Laanmets         
Ruppiner Kliniken GmbH Recruiting
Neuruppin, Germany
Contact: Kirk Schmailzl, M.D         
Principal Investigator: Kirk Schmailzl, M.D         
Heart Center Balatonfüred Recruiting
Balatonfüred, Hungary, 8230
Contact: Dániel Aradi, MD PhD    +36302355639   
Contact: Dezsi Dome         
Principal Investigator: Dániel Aradi, MD PhD         
Gottsegen Hungarian Institute of Cardiology Recruiting
Budapest, Hungary, 1096
Contact: Peter Andreka, MDPhD    +36 70 3820 270   
Contact: Geza Fontos, MD   
Principal Investigator: Peter Andreka, MDPhD         
Semmelweis University Heart and Vascular Center Recruiting
Budapest, Hungary, 1122
Contact: Istvan Jr. Edes Jr, MD    +36 1 45 86 810   
Contact: György Bärczi    +361 458 6810   
Principal Investigator: Bela Merkely, MDPhD         
Medical Centre Hungarian Defence Forces Recruiting
Budapest, Hungary, 1134
Contact: Dr. Robert Kiss    + 36 1 465 1966   
Contact: Andra Korda    +36302001436   
Principal Investigator: Dr. Robert Kiss         
Medical and Health Science Center University of Debrecen Recruiting
Debrecen, Hungary, 4032
Contact: Istvan Edes    + 36 52 414 928   
Contact: Ferenc Gyory    + 36 52 255 488   
Principal Investigator: Istvan Edes         
University of Miskolc Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital Recruiting
Miskolc, Hungary, 3526
Contact: Dr.Gergely G Nagy, MD    +36 20 9547016   
Contact: Erika Csengo, MD   
Principal Investigator: Dr.Gergely G Nagy, MD         
Heart Institute University of Pecs Recruiting
Pecs, Hungary, 7623
Contact: Ivan Horvath, MDPhDFESC    +36 30 3322339   
Contact: Balint Kittka    +36 72 536 001   
Principal Investigator: Ivan Horvath, MDPhDFESC         
Szent-Györgyi Albert Clinical Centre, II (University of Szeged) Recruiting
Szeged, Hungary, 6725
Contact: Imre Ungi    +36 625 46 492   
Contact: Andras Katona   
Principal Investigator: Imre Ungi         
Vilnius University Hospital (Santariskiu Klinikos, Santariskiu) Recruiting
Vilnius, Lithuania, 08661
Contact: Pranas Serpytis    +37068688996   
Contact: Rokas Serpytis    +370 610 89 860   
Principal Investigator: Pranas Serpytis         
Nicolaus Copernicus University, Collegium Medicum University Hospital Recruiting
Bydgoszcz, Poland, 85-094
Contact: Dr. Jacek Kubica, MD, PhD    +48 52 58 54 023   
Contact: Dr. Piotr Adamski    0048 60 75 10 221   
Principal Investigator: Dr. Jacek Kubica, MD, PhD         
Slaskiego Uniwersytetu Medycznego w Katowicach Recruiting
Katowice - Ochojec, Poland, 40-635
Contact: Andreij Ochala    +48 66 68 70 579   
Contact: Dr.Sebastin Dworowy   
Principal Investigator: Andreij Ochala         
Institute of Cardiology, Recruiting
Warsaw, Poland
Contact: Adam Witkowski, MD, PhD,FESC         
Principal Investigator: Adam Witkowski, MD, PhD,FESC         
Silesian Center for Heart Diseases, Zabrze Recruiting
Zabrze, Poland
Contact: Beata Sredniawa, MD PhD         
Principal Investigator: Beata Sredniawa, MD,PhD         
Medical University in Łódź, Bieganski Hospital Recruiting
Łódź, Poland
Contact: Jan Peruga, M.D, PhD         
Principal Investigator: Jan Peruga, M.D, PhD         
Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology) Recruiting
Belgrade, Serbia
Contact: Goran Stankovic    +381-11-3613653   
Contact: Vladan Vukcevic    +381-11-3613653   
Sub-Investigator: Vladan Vukcevic         
Institute of Cardiovascular Diseases Vojvodina Recruiting
Sremska Kamenica, Serbia, 21204
Contact: Milovan Petrovic    +381 64 11 53 076   
Contact: Ljiljana Pupic    +381 63 520 853   
Principal Investigator: Milovan Petrovic         
University Clinical Hospital Center Zemun Recruiting
Zemun, Serbia
Contact: Aleksandar Neskovic, MDPhD         
Contact: Srdjan Kafedzic    + 381 11 3447-835   
Principal Investigator: Aleksandar Neskovic, MDPhD         
United Kingdom
Essex Cardiothoracic Centre, Anglia Ruskin University Recruiting
Basildon, Essex, United Kingdom
Contact: John Davies         
Contact: Thomas Keeble, BScMDMCRP         
Sub-Investigator: Thomas Keeble, BScMDMCRP         
Principal Investigator: John Davies         
Royal Sussex County Hospital Recruiting
Brighton, United Kingdom, BN2 5BE
Contact: Adam De Belder    +44 1273 664494   
Contact: David Hildick Smith    +44 1273 664494   
Principal Investigator: Adam De Belder         
The London Barts Department of Cardiology Recruiting
London, United Kingdom, E2 9JX
Contact: Anthony Mathur    +44 208 983 2448   
Contact: Jessy Devanayegi         
Principal Investigator: Anthony Mathur         
Cardiac Research Sister, King's College Hospital Recruiting
London, United Kingdom
Contact: Rafal Dworakowski, M.D         
Principal Investigator: Rafal Dworakowski, M.D         
Manchester Heart Centre Manchester Royal InfirmaryCentral Manchester University Hospitals NHS Foundation Trust Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Hendry Cara   
Contact: Sarah Evans    + 44 161 276 3336   
Principal Investigator: Hendry Cara         
Sponsors and Collaborators
ZOLL Circulation, Inc., USA

Responsible Party: ZOLL Circulation, Inc., USA Identifier: NCT02070913     History of Changes
Other Study ID Numbers: EDC-2191
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by ZOLL Circulation, Inc., USA:
Acute Myocardial Infarction
Percutaneous Coronary Intervention
Therapeutic Hypothermia

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Body Temperature Changes
Signs and Symptoms