COOL-AMI EU Case Series Clinical Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 26, 2014
Last verified: June 2014
  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: Cohort
Time Perspective: Prospective
Official Title: COOL-AMI EU Case Series Clinical Study: 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 Acute Myocardial Infarction

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: 50
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
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

Locations
Germany
Klinik für allgemeine und interventionelle Kardiologie, Universitäres Herzzentrum Not yet recruiting
Hamburg, Germany
Contact: Patrick Diemert, M.D         
Principal Investigator: Patrick Diemert, M.D         
Ruppiner Kliniken GmbH Recruiting
Neuruppin, Germany
Contact: Kirk Schmailzl, M.D    00493391391011      
Principal Investigator: Kirk Schmailzl, M.D         
Poland
Department of Cardiology, Dr. Jurasz University Hospital, Bydgoszcz Withdrawn
Bydgoszcz, Poland
Invasive Cardiology Dept., Not yet recruiting
Katowice, Poland
Contact: Andrzej Ochała, M.D, PhD         
Principal Investigator: Andrzej Ochała, M.D, PhD         
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, Prof         
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         
United Kingdom
Essex Cardiothoracic Centre, Anglia Ruskin University Recruiting
Basildon, Essex, United Kingdom
Contact: John Davies    00447961424133    john.davies@btuh.nhs.uk   
Contact: Thomas Keeble, BSc,M.D,MCRP    00441268394673    thomaskeeble@hotmail.com   
Sub-Investigator: Thomas Keeble, BSc, M.D, MCRP         
Principal Investigator: John Davies         
Cardiac Research Sister, King's College Hospital Recruiting
London, United Kingdom
Contact: Rafal Dworakowski, M.D    00442032994967    rdworakowski@nhs.net   
Principal Investigator: Rafal Dworakowski, M.D         
Sponsors and Collaborators
ZOLL Circulation, Inc., USA
  More Information

No publications provided

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: June 26, 2014
Health Authority: Poland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 28, 2014