COOL-AMI EU Case Series Clinical Study

NCT02070913 | Completed

• 1 other identifier: EDC-2191
• Study Type: observational
• Target: 352
• Locations: 8 countries
• Sites: 23

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.

Conditions

Acute Myocardial Infarction

Keywords

Hypothermia; Acute Myocardial Infarction; Percutaneous Coronary Intervention; AMI; PCI; Therapeutic Hypothermia

Outcome Measures

Primary Outcomes (3)

• Time from hospital arrival to Percutaneous Coronary Intervention (PCI).

  24 hours

• Time from hospital arrival to initiation of cooling.

  24 hours

• Proportion of subjects achieving target temperature.

  24 hours

Secondary Outcomes (1)

• Proportion of those enrolled that complete the study protocol.

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ZOLL Circulation, Inc., USA: lead

Study Sites (23)

University Hospital Brno, Internal and Cardiology Department

Brno, 625 00, Czechia

Location

North Estonia Medical Center

Tallinn, 13419, Estonia

Location

Ruppiner Kliniken GmbH

Neuruppin, Germany

Location

Heart Center Balatonfüred

Balatonfüred, 8230, Hungary

Location

Gottsegen Hungarian Institute of Cardiology

Budapest, 1096, Hungary

Location

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

Location

Medical Centre Hungarian Defence Forces

Budapest, 1134, Hungary

Location

Medical and Health Science Center University of Debrecen

Debrecen, 4032, Hungary

Location

University of Miskolc Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital

Miskolc, 3526, Hungary

Location

Heart Institute University of Pecs

Pécs, 7623, Hungary

Location

Szent-Györgyi Albert Clinical Centre, II (University of Szeged)

Szeged, 6725, Hungary

Location

Vilnius University Hospital (Santariskiu Klinikos, Santariskiu)

Vilnius, 08661, Lithuania

Location

Nicolaus Copernicus University, Collegium Medicum University Hospital

Bydgoszcz, 85-094, Poland

Location

Medical University in Łódź, Bieganski Hospital

Lodz, Poland

Location

Institute of Cardiology,

Warsaw, Poland

Location

Silesian Center for Heart Diseases, Zabrze

Zabrze, Poland

Location

Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)

Belgrade, Serbia

Location

Institute of Cardiovascular Diseases Vojvodina

Kamenitz, 21204, Serbia

Location

University Clinical Hospital Center Zemun

Zemun, Serbia

Location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

The London Barts Department of Cardiology

London, E2 9JX, United Kingdom

Location

Cardiac Research Sister, King's College Hospital

London, United Kingdom

Location

Manchester Heart Centre Manchester Royal InfirmaryCentral Manchester University Hospitals NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: February 25, 2014
• Study Start: September 1, 2013
• Primary Completion: April 16, 2019
• Study Completion: April 16, 2019
• Last Updated: November 27, 2020

Record last verified: 2020-06

Locations

SE (3); ES (1); HU (8); LI (1); PL (4); CZ (1); GB (4); DE (1)