Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients (VELOCITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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.

July 30, 2012
August 1, 2012
July 25, 2014
November 2012
March 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01655433 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients
VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • ST-elevation MI
  • Hypothermia
  • Device: Velomedix APLS device
    Velomedix, Automated Peritoneal Lavage System
  • Other: No Hypothermia Treatment
  • Experimental: Therapeutic Hypothermia Treatment
    Intervention: Device: Velomedix APLS device
  • Active Comparator: No Hypothermia Treatment
    control group is no hypothermia treatment
    Intervention: Other: No Hypothermia Treatment
Nichol G, Strickland W, Shavelle D, Maehara A, Ben-Yehuda O, Genereux P, Dressler O, Parvataneni R, Nichols M, McPherson J, Barbeau G, Laddu A, Elrod JA, Tully GW, Ivanhoe R, Stone GW; VELOCITY Investigators. Prospective, multicenter, randomized, controlled pilot trial of peritoneal hypothermia in patients with ST-segment- elevation myocardial infarction. Circ Cardiovasc Interv. 2015 Mar;8(3):e001965. doi: 10.1161/CIRCINTERVENTIONS.114.001965. Epub 2015 Feb 19.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
Not Provided
Not Provided
Velomedix, Inc.
Velomedix, Inc.
Not Provided
Principal Investigator: Gregg Stone, MD New York Presbyterian Hospital / Columbia University Medical Center
Principal Investigator: Graham Nichol, MD University of Washington, Harberview Center
Velomedix, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP