Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients
Stopped early · Phase 2
Conditions studied: ST-elevation MI, Hypothermia
In brief
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.
Key facts
- Study ID
- NCT01655433
- Run by
- Velomedix, Inc.
- People needed
- 54
- Starts
- 2012-11-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2014-07-25
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Heart Center Research, LLC — Huntsville, Alabama, United States
- LA County USC Hospital — Los Angeles, California, United States
- Northeast Georgia Medical Center — Gainesville, Georgia, United States
- Ochsner Medical Center — New Orleans, Louisiana, United States
- Vanderbilt University — Nashville, Tennessee, United States
- Victoria Heart Institute Foundation — Victoria, British Columbia, Canada
- Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval) — Québec, Quebec, Canada
Full record on ClinicalTrials.gov
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