Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients (VELOCITY)
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ClinicalTrials.gov Identifier: NCT01655433 |
Recruitment Status
:
Terminated
(Sponsor business decision, not safety related)
First Posted
: August 1, 2012
Last Update Posted
: July 25, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
ST-elevation MI Hypothermia | Device: Velomedix APLS device Other: No Hypothermia Treatment | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Therapeutic Hypothermia Treatment |
Device: Velomedix APLS device
Velomedix, Automated Peritoneal Lavage System
|
Active Comparator: No Hypothermia Treatment
control group is no hypothermia treatment
|
Other: No Hypothermia Treatment |
- Composite of new-onset SAEs [ Time Frame: 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.
- MACE rate [ Time Frame: 30 days ]MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days
- All cause mortality [ Time Frame: 6 months ]All cause mortality through 6 months
- Myocardial infarct size [ Time Frame: 3 days ]Myocardial infarct size at 3 days post-procedure

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655433
United States, Alabama | |
Heart Center Research, LLC | |
Huntsville, Alabama, United States, 35801 | |
United States, California | |
LA County USC Hospital | |
Los Angeles, California, United States | |
United States, Georgia | |
Northeast Georgia Medical Center | |
Gainesville, Georgia, United States, 30501 | |
United States, Louisiana | |
Ochsner Medical Center | |
New Orleans, Louisiana, United States | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States | |
Canada, British Columbia | |
Victoria Heart Institute Foundation | |
Victoria, British Columbia, Canada, VSR 4R2, | |
Canada, Quebec | |
Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval) | |
Quebec City, Quebec, Canada, G1V 4G5 |
Principal Investigator: | Gregg Stone, MD | New York Presbyterian Hospital / Columbia University Medical Center | |
Principal Investigator: | Graham Nichol, MD | University of Washington, Harberview Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Velomedix, Inc. |
ClinicalTrials.gov Identifier: | NCT01655433 History of Changes |
Other Study ID Numbers: |
VMXP-2490 |
First Posted: | August 1, 2012 Key Record Dates |
Last Update Posted: | July 25, 2014 |
Last Verified: | July 2014 |
Keywords provided by Velomedix, Inc.:
ST-elevation MI Hypothermia |
Additional relevant MeSH terms:
Hypothermia ST Elevation Myocardial Infarction Body Temperature Changes Signs and Symptoms Myocardial Infarction |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |