COOL-AMI EU Case Series Clinical Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Myocardial Infarction

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, Acute Myocardial Infarction, Percutaneous Coronary Intervention, AMI, PCI, Therapeutic Hypothermia