Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients - Full Text View

Purpose

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	Intervention	Phase
ST-elevation MI Hypothermia	Device: Velomedix APLS device Other: No Hypothermia Treatment	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Hypothermia

U.S. FDA Resources

Further study details as provided by Velomedix, Inc.:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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


Enrollment:	54
Study Start Date:	November 2012
Study Completion Date:	March 2014
Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655433

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

No publications provided


Responsible Party:	Velomedix, Inc.
ClinicalTrials.gov Identifier:	NCT01655433 History of Changes
Other Study ID Numbers:	VMXP-2490
Study First Received:	July 30, 2012
Last Updated:	July 24, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Velomedix, Inc.:


ST-elevation MI Hypothermia

Additional relevant MeSH terms:


Hypothermia Body Temperature Changes Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015

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