Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?

Study Overview
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Brief Summary
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The hypothesis of this study is that consciously sedated patients suffering from ST-elevation myocardial infarction can be rapidly and safely cooled to a state of therapeutic hypothermia (32 to 34 degrees C) using the LRS ThermoSuit System prior to percutaneous coronary intervention.

Detailed Description
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This clinical study will investigate the safety and feasibility of cooling heart attack (STEMI) patients with the LRS (Life Recovery Systems)ThermoSuit System, a cooling device which uses the principle of cold water immersion to rapidly reduce patient temperature. The study will enroll a total of up to 20 patients, and will be a cooperative effort between LRS and LSU Health Sciences Center - Shreveport. The study is being conducted under an IDE (Investigational Device Exemption) that was granted to LRS by FDA (G070141). The primary goal of this trial is to demonstrate the feasibility of cooling AMI patients pre-reperfusion with the ThermoSuit cooling device. The safety of this treatment will be determined by review of a composite of serious adverse events. Consciously sedated patients will be cooled after entry into the emergency room and prior to percutaneous coronary intervention in the catheterization laboratory. It is hypothesized that the ThermoSuit System will enable cooling of the patient to 34ºC after a treatment of 30 minutes or less. Previous research has suggested that cooling of ST-elevation myocardial infarction patients before coronary reperfusion could result in a significant reduction in myocardial infarct size. If successful, this study will lead to a pivotal clinical study to investigate the potential for the ThermoSuit cooling treatment to reduce myocardial infarct size. The ultimate goal of these studies is to determine the safety and effectiveness of the use of the ThermoSuit device for the treatment of AMI patients.

Official Title
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Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?

Conditions
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ST-Elevation Myocardial Infarction

Intervention / Treatment
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* Device: Life Recovery Systems ThermoSuit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Duration of MI symptoms ≥ 30 minutes to ≤ 6 hours. ST-segment elevation of ≥ 1mm or more in two or more contiguous leads. Eligible for PCI. Willingness of patient or legal guardian to provide written, informed consent. Patient dimension criteria: Height: 147-190 cm (58 - 75 in) Width: ≤73 cm (29 in) (elbow to elbow) Exclusion Criteria: Cardiac arrest or previous MI within one month. Administration of thrombolytics. Cardiogenic shock (systolic blood pressure (SBP) < 80 mmHg for > 30 minutes or SBP < 100 mmHg on vasopressors or IABP) in the absence of bradycardia or other correctable causes. Known hypersensitivity to hypothermia including Raynaud's disease or cryoglobulinemia. Severe allergy or contraindication to aspirin, Plavix, heparin, or contrast media which cannot be adequately pre-medicated. History of bleeding diathesis or coagulopathy or refusal of blood transfusions. Pregnancy. Known hypersensitivity midazolam, meperidine, buspirone, or magnesium sulfate. Current enrollment in another clinical trial (other than registry). Temperature < 35°C on admission to Emergency Department. Recent (< 1 week) surgical incisions.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ThermoSuit-Induced Patient Cooling<br>The Life Recovery Systems ThermoSuit System will be used to cool STEMI patients under conditions of conscious sedation. | Device: Life Recovery Systems ThermoSuit<br>* Hypothermia induction (cooling to 32 to 34 degrees C core temperature) using the Life Recovery Systems ThermoSuit System (a device which cools patients using direct skin contact with cold water) followed by PCI (percutaneous coronary intervention) and maintenance of hypothermia for 3 hours following PCI.<br>* Other names: Life Recovery Systems ThermoSuit(R) System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of use of cooling device as determined by ability and time to achieve target temperature and ease of maintaining temperature in therapeutic range (32 to 34°C) for three hours following removal of patient from ThermoSuit. |  | Four hours | 
| Primary safety endpoint: composite of serious adverse events including: death, re-infarction, ischemia-driven TVR, pneumonia, sepsis, arrhythmia, bleeding, stroke, and renal failure. |  | 30 days post-hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events at 30 days as defined by death or non-fatal re-infarction. c. Ischemia-driven target vessel revascularization. |  | 30 days post-hospital discharge | 
| Myocardial infarct size at 30 days as measured by 99mTc-sestamibi SPECT imaging. |  | 30 days post-hospital discharge | 
| Safety, including all-cause mortality, cardiac, vascular, and hematological complications. |  | 30 days post-hospital discharge | 
| Adverse events associated with conscious sedation. |  | 30 days post-hospital discharge | 
| Arterial blood pressure and heart rate every 5 minutes from the baseline just before the start of cooling until 30 minutes after cooling has started. |  | One hour | 
| Door to balloon time. |  | 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction, Hypothermia, Induced