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

This study has been terminated.
(Sponsor business decision, not safety related)
Sponsor:
Information provided by (Responsible Party):
Velomedix, Inc.
ClinicalTrials.gov Identifier:
NCT01655433
First received: July 30, 2012
Last updated: July 24, 2014
Last verified: July 2014

July 30, 2012
July 24, 2014
November 2012
March 2014   (final data collection date for primary outcome measure)
Composite of new-onset SAEs [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
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 ClinicalTrials.gov Archive Site
  • MACE rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    All cause mortality through 6 months
  • Myocardial infarct size [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
54
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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01655433
VMXP-2490
Yes
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