Hypothermia, ST-elevation MI
Conditions
Keywords
ST-elevation MI, Hypothermia
Brief summary
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
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.
Interventions
DEVICEVelomedix APLS device
Velomedix, Automated Peritoneal Lavage System
OTHERNo Hypothermia Treatment
Sponsors
Velomedix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of new-onset SAEs | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE rate | 30 days | MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days |
| All cause mortality | 6 months | All cause mortality through 6 months |
| Myocardial infarct size | 3 days | Myocardial infarct size at 3 days post-procedure |
Countries
Canada, United States
Outcome results
None listed