COOL-AMI EU Case Series Clinical Study

Acute Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070913
• Other study ID #: EDC-2191
• Status: Completed
• Start date: September 2013
• Est. completion date: April 16, 2019

Study information

• Verified date: June 2020
• Source: ZOLL Circulation, Inc., USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: April 16, 2019
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Hypothermia
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Czechia	University Hospital Brno, Internal and Cardiology Department	Brno
Estonia	North Estonia Medical Center	Tallinn
Germany	Ruppiner Kliniken GmbH	Neuruppin
Hungary	Heart Center Balatonfüred	Balatonfüred
Hungary	Gottsegen Hungarian Institute of Cardiology	Budapest
Hungary	Medical Centre Hungarian Defence Forces	Budapest
Hungary	Semmelweis University Heart and Vascular Center	Budapest
Hungary	Medical and Health Science Center University of Debrecen	Debrecen
Hungary	University of Miskolc Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital	Miskolc
Hungary	Heart Institute University of Pecs	Pecs
Hungary	Szent-Györgyi Albert Clinical Centre, II (University of Szeged)	Szeged
Lithuania	Vilnius University Hospital (Santariskiu Klinikos, Santariskiu)	Vilnius
Poland	Nicolaus Copernicus University, Collegium Medicum University Hospital	Bydgoszcz
Poland	Medical University in Lódz, Bieganski Hospital	Lódz
Poland	Institute of Cardiology,	Warsaw
Poland	Silesian Center for Heart Diseases, Zabrze	Zabrze
Serbia	Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)	Belgrade
Serbia	Institute of Cardiovascular Diseases Vojvodina	Sremska Kamenica
Serbia	University Clinical Hospital Center Zemun	Zemun
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Cardiac Research Sister, King's College Hospital	London
United Kingdom	The London Barts Department of Cardiology	London
United Kingdom	Manchester Heart Centre Manchester Royal InfirmaryCentral Manchester University Hospitals NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
ZOLL Circulation, Inc., USA

Countries where clinical trial is conducted

Czechia,  Estonia,  Germany,  Hungary,  Lithuania,  Poland,  Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from hospital arrival to Percutaneous Coronary Intervention (PCI).		24 hours
Primary	Time from hospital arrival to initiation of cooling.		24 hours
Primary	Proportion of subjects achieving target temperature.		24 hours
Secondary	Proportion of those enrolled that complete the study protocol.		24 hours