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

July 24, 2014 updated by: Velomedix, Inc.

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Victoria, British Columbia, Canada, VSR 4R2,
        • Victoria Heart Institute Foundation
    • Quebec
      • Quebec City, Quebec, Canada, G1V 4G5
        • Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval)
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC
    • California
      • Los Angeles, California, United States
        • LA County USC Hospital
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States
        • Ochsner Medical Center
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic Hypothermia Treatment
Velomedix, Automated Peritoneal Lavage System
Active Comparator: No Hypothermia Treatment
control group is no hypothermia treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE rate
Time Frame: 30 days
MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days
30 days
All cause mortality
Time Frame: 6 months
All cause mortality through 6 months
6 months
Myocardial infarct size
Time Frame: 3 days
Myocardial infarct size at 3 days post-procedure
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Gregg Stone, MD, New York Presbyterian Hospital / Columbia University Medical Center
  • Principal Investigator: Graham Nichol, MD, University of Washington, Harberview Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 30, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (Estimate)

August 1, 2012

Study Record Updates

Last Update Posted (Estimate)

July 25, 2014

Last Update Submitted That Met QC Criteria

July 24, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VMXP-2490

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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