COOL-AMI EU Case Series Clinical Study

November 23, 2020 updated by: ZOLL Circulation, Inc., USA

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

352

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 625 00
        • University Hospital Brno, Internal and Cardiology Department
  • Estonia
      • Tallinn, Estonia, 13419
        • North Estonia Medical Center
  • Germany
      • Neuruppin, Germany
        • Ruppiner Kliniken GmbH
  • Hungary
      • Balatonfüred, Hungary, 8230
        • Heart Center Balatonfüred
      • Budapest, Hungary, 1122
        • Semmelweis University Heart and Vascular Center
      • Budapest, Hungary, 1134
        • Medical Centre Hungarian Defence Forces
      • Budapest, Hungary, 1096
        • Gottsegen Hungarian Institute of Cardiology
      • Debrecen, Hungary, 4032
        • Medical and Health Science Center University of Debrecen
      • Miskolc, Hungary, 3526
        • University of Miskolc Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital
      • Pecs, Hungary, 7623
        • Heart Institute University of Pecs
      • Szeged, Hungary, 6725
        • Szent-Györgyi Albert Clinical Centre, II (University of Szeged)
  • Lithuania
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital (Santariskiu Klinikos, Santariskiu)
  • Poland
      • Bydgoszcz, Poland, 85-094
        • Nicolaus Copernicus University, Collegium Medicum University Hospital
      • Warsaw, Poland
        • Institute of Cardiology,
      • Zabrze, Poland
        • Silesian Center for Heart Diseases, Zabrze
      • Łódź, Poland
        • Medical University in Łódź, Bieganski Hospital
  • Serbia
      • Belgrade, Serbia
        • Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)
      • Sremska Kamenica, Serbia, 21204
        • Institute of Cardiovascular Diseases Vojvodina
      • Zemun, Serbia
        • University Clinical Hospital Center Zemun
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • London, United Kingdom, E2 9JX
        • The London Barts Department of Cardiology
      • London, United Kingdom
        • Cardiac Research Sister, King's College Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester Heart Centre Manchester Royal InfirmaryCentral Manchester University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from hospital arrival to Percutaneous Coronary Intervention (PCI).
Time Frame: 24 hours
24 hours
Time from hospital arrival to initiation of cooling.
Time Frame: 24 hours
24 hours
Proportion of subjects achieving target temperature.
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of those enrolled that complete the study protocol.
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZOLL Circulation, Inc., USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

April 16, 2019

Study Completion (Actual)

April 16, 2019

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 25, 2014

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDC-2191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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