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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
Information provided by (Responsible Party):
Velomedix, Inc.

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.

Condition or disease Intervention/treatment Phase
ST-elevation MI Hypothermia Device: Velomedix APLS device Other: No Hypothermia Treatment Phase 2

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.

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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

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. MACE rate [ Time Frame: 30 days ]
    MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days

  2. All cause mortality [ Time Frame: 6 months ]
    All cause mortality through 6 months

  3. Myocardial infarct size [ Time Frame: 3 days ]
    Myocardial infarct size at 3 days post-procedure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

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

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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
Sponsors and Collaborators
Velomedix, Inc.
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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):
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Responsible Party: Velomedix, Inc.
ClinicalTrials.gov Identifier: NCT01655433    
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
Additional relevant MeSH terms:
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Body Temperature Changes