COOL AMI EU Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction

Study Overview
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Brief Summary
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COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction. Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.

Detailed Description
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Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.

Official Title
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COOL-AMI EU PILOT TRIAL: A Multicenter, Prospective, Randomized Controlled Trial To Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With ACUTE MYOCARDIAL INFARCTION

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Device: Cooling + PCI
* Device: PCI only


Participation Criteria
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Eligibility Criteria
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All Inclusion Criteria must be answered YES for subject to be eligible for trial Inclusion Criteria: ≥ 18 years of age. symptoms consistent with AMI (chest pain, unresponsive to nitroglycerin, ≥ 30 minutes and < 6 hours. Anterior MI with ST-segment elevation of 0.2 mV in two or more anterior contiguous precordial leads. Eligible for PCI. Opportunity for at least 10 minutes of cooling with the Proteus IVTM System prior to PCI. Written, informed consent to participate in this clinical trial. Exclusion Criteria: All Exclusion Criteria must be answered NO for subject to be eligible for trial inclusion. Previous myocardial infarction. Cardiogenic shock (systolic blood pressure [SBP] <80 mmHg and non-responsive to fluids, or SBP <100 mmHg with vasopressors, or requirement for an intra-aortic balloon pump [IABP]). Resuscitated cardiac arrest, atrial fibrillation, or Killip risk stratification class II through IV Aortic dissection or requires an immediate surgical or procedural intervention other than PCI Congestive Heart Failure (CHF), hepatic failure, end- stage kidney disease or severe renal failure (clearance < 30ml/min/1.73m2). Fever (temperature > 37.5 °C) or infection with fever in the last 5 days. Previous CABG. Stroke within 90 days of admission. Cardio-pulmonary decompensation present or imminent Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis (e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans) Hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated. History of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, or will refuse blood transfusions. Height of <1.5 meters (4 feet 11 inches). Hypersensitivity to buspirone hydrochloride or Pethidine (Meperidine) and/or treatment with a monoamine oxidase inhibitor in the past 14 days. History of severe hepatic or renal impairment, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture that in the opinion of the physician would be incompatible with Pethidine administration. Inferior Vena Cava filter in place (IVC). The patient has a pre-MI life expectancy of <1 year due to underlying medical conditions or pre-existing co-morbidities. Known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions. Currently enrolled in another investigational drug or device trial that has not completed the primary endpoint. Apprehension or unwilling to undergo the required MRI imaging at follow-up, has a documented or suspected diagnosis of claustrophobia, or has Gadolinium allergy Received thrombolytic therapy en route to the hospital Clinical evidence of spontaneous reperfusion as observed symptomatically and/ or from ECG findings (partial or complete ST resolution in ECG before randomization) upon admission Vulnerable subject, for instance, a person in detention (i.e., prisoner or ward of the state) Female who is known to be pregnant.

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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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cooling + PCI<br>The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Proteus IVTM System before and after PCI. | Device: Cooling + PCI<br>* Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI)<br>|
| Other: PCI only<br>The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow PCI only. | Device: PCI only<br>* Standard of Care for PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period |  | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Anterior Infarct Size (IS) as assessed by Cardiac Magnetic Resonance (cMR) at 4 - 6 days following the index procedure for subjects in Test and Control Arms |  | 4 - 6 days | 

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