Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients

Study Overview
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Brief Summary
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This study will look at the safety of treating patients with heart attack with mild hypothermia induced using a system of automated peritoneal lavage. The hypothesis is that the Velomedix Automated Peritoneal Lavage System can treat patients with heart attack safely and with adequate performance.

Detailed Description
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The study aims to determine the safety and feasibility of using the Velomedix Automated Peritoneal Lavage System to treat patients with STEMI using therapeutic hypothermia. Patients will undergo cooling, maintenance and rewarming and applicable data will be gathered on device performance and patient safety. Patient temperature and vital signs will be monitored in addition to various laboratory values. Adverse event reporting will take place at multiple time intervals and follow-up will continue out to 6-months.

Official Title
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VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction

Conditions
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ST-elevation MI, Hypothermia

Intervention / Treatment
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* Device: Velomedix APLS device
* Other: No Hypothermia Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical symptoms consistent with acute STEMI lasting at least 30 minutes STEMI with ST-Elevation of ≥2 mm in two or more contiguous ECG leads Patient eligible for PCI Exclusion Criteria: Cardiac arrest with return of spontaneous circulation Known prior history of MI Known history of severe COPD requiring supplemental home oxygen Patient experiencing intractable cardiogenic shock, or requiring immediate placement of a mechanical cardiac assist device Known severe anemia or abnormal platelet count Known significant renal insufficiency Known contraindication for MRI Known contraindications to hypothermia, such as temperature-sensitive hematological dyscrasias or vasospastic disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Hypothermia Treatment<br> | Device: Velomedix APLS device<br>* Velomedix, Automated Peritoneal Lavage System<br>|
| Active Comparator: No Hypothermia Treatment<br>control group is no hypothermia treatment | Other: No Hypothermia Treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of new-onset SAEs | Composite of new-onset serious adverse events, specifically death, ischemia driven target vessel revascularization (TVR), recurrent MI, pneumonia, sepsis, ventricular tachycardia or fibrillation requiring cardioversion, renal failure, peritonitis and significant bleeding. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE rate | MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days | 30 days | 
| All cause mortality | All cause mortality through 6 months | 6 months | 
| Myocardial infarct size | Myocardial infarct size at 3 days post-procedure | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST-elevation MI, Hypothermia