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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by ZOLL Circulation, Inc., USA
Sponsor:
Information provided by (Responsible Party):
ZOLL Circulation, Inc., USA
ClinicalTrials.gov Identifier:
NCT02070913
First received: September 24, 2013
Last updated: July 12, 2016
Last verified: July 2016
  Purpose
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
Acute Myocardial Infarction

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by ZOLL Circulation, Inc., USA:

Primary Outcome Measures:
  • Time from hospital arrival to Percutaneous Coronary Intervention (PCI). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Time from hospital arrival to initiation of cooling. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving target temperature. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of those enrolled that complete the study protocol. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070913

Contacts
Contact: Renée Kochevar rkochevar@zoll.com
Contact: Tracy Roberts 408 419 2968 troberts@zoll.com

Locations
Czech Republic
University Hospital Brno, Internal and Cardiology Department Recruiting
Brno, Czech Republic, 625 00
Contact: Petr Kala, MDPhD    +420532232205    kalapetr7@gmail.com   
Contact: Roman Millkik, MD    +420532232205    romanmiklik@yahoo.com   
Principal Investigator: Petr Kala, MDPhD         
Estonia
North Estonia Medical Center Recruiting
Tallinn, Estonia, 13419
Contact: Peep Laanmets    + 372 617 1199    Peep.Laanmets@regionaalhaigla.ee   
Contact: Jaanus Laanoja       Jaanus.Laanoja@regionaalhaigla.ee   
Principal Investigator: Peep Laanmets         
Germany
Ruppiner Kliniken GmbH Recruiting
Neuruppin, Germany
Contact: Kirk Schmailzl, M.D         
Principal Investigator: Kirk Schmailzl, M.D         
Hungary
Heart Center Balatonfüred Recruiting
Balatonfüred, Hungary, 8230
Contact: Dániel Aradi, MD PhD    +36302355639    daniel_aradi@yahoo.com   
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    andreka.peter@kardio.hu   
Contact: Geza Fontos, MD       geza.fontos@kardio.hu   
Principal Investigator: Peter Andreka, MDPhD         
Semmelweis University Heart and Vascular Center Recruiting
Budapest, Hungary, 8995
Contact: Bela Merkely, MDPhD    +361 458 6840    studycenter.sekk2@gmail.com   
Contact: György Bärczi    +361 458 6810    barczigyuri@hotmail.com   
Principal Investigator: Bela Merkely, MDPhD         
Medical and Health Science Center University of Debrecem Recruiting
Debrecem, Hungary, 4004
Contact: Istvan Edes    + 36 52 414 928    Edes@med.unideb.hu   
Contact: Ferenc Gyory    + 36 52 255 488    gyorydok@gmail.com   
Principal Investigator: Istvan Edes         
Heart Institute University of Pecs Recruiting
Pecs, Hungary
Contact: Ivan Horvath, MDPhDFESC    +36 30 3322339    ivan.g.horvath@pte.hu   
Contact: Balint Kittka    +36 72 536 001      
Principal Investigator: Ivan Horvath, MDPhDFESC         
Lithuania
Vilnius University Hospital (Santariskiu Klinikos, Santariskiu) Recruiting
Vilnius, Lithuania, 08661
Contact: Pranas Serpytis    +37068688996    pranas.serpytis@santa.lt   
Contact: Rokas Serpytis    +370 610 89 860    rokas.serpytis@santa.lt   
Principal Investigator: Pranas Serpytis         
Poland
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         
Serbia
Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology) Recruiting
Belgrade, Serbia
Contact: Goran Stankovic    +381-11-3613653    goranstan@gmail.com   
Contact: Vladan Vukcevic    +381-11-3613653    vladan.vukcevic@gmail.com   
Sub-Investigator: Vladan Vukcevic         
University Clinical Hospital Center Zemun Recruiting
Zemun, Serbia
Contact: Aleksandar Neskovic, MDPhD         
Contact: Srdjan Kafedzic    + 381 11 3447-835    skafedzic@yahoo.com   
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    Adam.deBelder@bsuh.nhs.uk   
Contact: David Hildick Smith    +44 1273 664494    David.Hildick-Smith@bsuh.nhs.uk   
Principal Investigator: Adam De Belder         
The London Barts Department of Cardiology Recruiting
London, United Kingdom, E2 9JX
Contact: Anthony Mathur    +44 208 983 2448    a.mathur@qmul.ac.uk   
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       Cara.Hendry@cmft.nhs.uk   
Contact: Sarah Evans    + 44 161 276 3336    sarah.evansmhc@cmft.nhs.uk   
Principal Investigator: Hendry Cara         
Sponsors and Collaborators
ZOLL Circulation, Inc., USA
  More Information

Responsible Party: ZOLL Circulation, Inc., USA
ClinicalTrials.gov Identifier: NCT02070913     History of Changes
Other Study ID Numbers: EDC-2191 
Study First Received: September 24, 2013
Last Updated: July 12, 2016
Health Authority: Poland: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Undecided

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

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

ClinicalTrials.gov processed this record on August 23, 2016