COOL-AMI EU Case Series Clinical Study

Completed

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT02070913
• Lead Sponsor: ZOLL Circulation, Inc., USA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-25
• Primary Completion: 2019-04-16
• Study Completion: 2019-04-16
• Status Verified: 2020-06
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of those enrolled that complete the study protocol.	24 hours

Trial Locations

Locations (23)

University Hospital Brno, Internal and Cardiology Department; 🇨🇿 Brno, Czechia

North Estonia Medical Center; 🇪🇪 Tallinn, Estonia

Ruppiner Kliniken GmbH; 🇩🇪 Neuruppin, Germany

Heart Center Balatonfüred; 🇭🇺 Balatonfüred, Hungary

Gottsegen Hungarian Institute of Cardiology; 🇭🇺 Budapest, Hungary

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary

Medical Centre Hungarian Defence Forces; 🇭🇺 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

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