- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01655433
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
Status
Terminated
Conditions
Intervention / Treatment
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
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Quebec City, Quebec, Canada, G1V 4G5
- Institut Universitaire de cardiologie et pneumologie de Québec (Hopital Laval)
-
-
-
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Alabama
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Huntsville, Alabama, United States, 35801
- Heart Center Research, LLC
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-
California
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Los Angeles, California, United States
- LA County USC Hospital
-
-
Georgia
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Gainesville, Georgia, United States, 30501
- Northeast Georgia Medical Center
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-
Louisiana
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New Orleans, Louisiana, United States
- Ochsner Medical Center
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Tennessee
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Nashville, Tennessee, United States
- Vanderbilt University
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-
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
Keywords
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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