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

Primary Purpose

ST-elevation MI, Hypothermia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Velomedix APLS device
No Hypothermia Treatment
Sponsored by
Velomedix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-elevation MI focused on measuring ST-elevation MI, Hypothermia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Center Research, LLC
  • LA County USC Hospital
  • Northeast Georgia Medical Center
  • Ochsner Medical Center
  • Vanderbilt University
  • Victoria Heart Institute Foundation
  • Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therapeutic Hypothermia Treatment

No Hypothermia Treatment

Arm Description

control group is no hypothermia treatment

Outcomes

Primary Outcome Measures

Composite of new-onset SAEs
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

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

Full Information

First Posted
July 30, 2012
Last Updated
July 24, 2014
Sponsor
Velomedix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01655433
Brief Title
Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients
Acronym
VELOCITY
Official Title
VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
Sponsor business decision, not safety related
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Velomedix, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation MI, Hypothermia
Keywords
ST-elevation MI, Hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Hypothermia Treatment
Arm Type
Experimental
Arm Title
No Hypothermia Treatment
Arm Type
Active Comparator
Arm Description
control group is no hypothermia treatment
Intervention Type
Device
Intervention Name(s)
Velomedix APLS device
Intervention Description
Velomedix, Automated Peritoneal Lavage System
Intervention Type
Other
Intervention Name(s)
No Hypothermia Treatment
Primary Outcome Measure Information:
Title
Composite of new-onset SAEs
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
MACE rate
Description
MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days
Time Frame
30 days
Title
All cause mortality
Description
All cause mortality through 6 months
Time Frame
6 months
Title
Myocardial infarct size
Description
Myocardial infarct size at 3 days post-procedure
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregg Stone, MD
Organizational Affiliation
New York Presbyterian Hospital / Columbia University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Graham Nichol, MD
Organizational Affiliation
University of Washington, Harberview Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
LA County USC Hospital
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Victoria Heart Institute Foundation
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
VSR 4R2,
Country
Canada
Facility Name
Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25699687
Citation
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.
Results Reference
derived

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Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients

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