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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
ST-elevation MI; Hypothermia	Device: Velomedix APLS device; Other: No Hypothermia Treatment	Phase 2

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	54 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction
Study Start Date :	November 2012
Actual Primary Completion Date :	March 2014
Actual Study Completion Date :	March 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Therapeutic Hypothermia Treatment	Device: Velomedix APLS device; Velomedix, Automated Peritoneal Lavage System
Active Comparator: No Hypothermia Treatment; control group is no hypothermia treatment	Other: No Hypothermia Treatment

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Velomedix, Inc.

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Velomedix, Inc.
ClinicalTrials.gov Identifier:	NCT01655433 History of Changes
Other Study ID Numbers:	VMXP-2490
First Posted:	August 1, 2012
Last Update Posted:	July 25, 2014
Last Verified:	July 2014

Keywords provided by Velomedix, Inc.:

ST-elevation MI; Hypothermia

Additional relevant MeSH terms:

Hypothermia; ST Elevation Myocardial Infarction; Body Temperature Changes; Signs and Symptoms; Myocardial Infarction	Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases